Devices, methods and systems for wireless control of medical devices

ABSTRACT

A medical device system. The system includes a first medical device, a first remote interface, and a second remote interface in communication with the first remote interface and the first medical device, wherein the first medical device sends a command to the first medical device through the second remote interface, and wherein when the second remote interface receives the command, the command must be confirmed by the second remote interface before the command is send by the second remote interface to the first medical device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation of U.S. patent applicationSer. No. 14/173,359, filed Feb. 5, 2014 and entitled Devices, Methodsand Systems for Wireless Control of Medical Devices, now U.S. Pat. No.10,195,343, issued Feb. 5, 2019, which is a Non-Provisional applicationwhich claims the benefit of U.S. Provisional Patent Application Ser. No.61/760,988, filed Feb. 5, 2013 and entitled Devices, Methods and Systemsfor Wireless Control or Medical Devices; and U.S. Provisional PatentApplication Ser. No. 61/842,687, filed Jul. 3, 2013 and entitledDevices, Methods and Systems for Wireless Control or Medical Devices,each of which is hereby incorporated herein by reference in theirentireties.

U.S. patent application Ser. No. 14/173,359, is also aContinuation-in-Part Application of U.S. patent application Ser. No.14/236,381, filed Jan. 31, 2014 and entitled Devices, Methods andSystems for Wireless Control of Medical Devices which is a '371Application of International Application Serial No. PCT/US12/71280,filed Dec. 21, 2012 and entitled Devices, Methods and Systems forWireless Control of Medical Devices, now International Publication No.WO 2013/096789, published Jun. 27, 2013, which is an InternationalApplication claiming priority to U.S. patent application Ser. No.13/332,896, filed Dec. 21, 2011 and entitled Devices, Methods andSystems for Wireless Control of Medical Devices, now U.S. PublicationNo. US-2012-0238851-A1, published Sep. 20, 2012, each of which is herebyincorporated herein by reference in their entireties.

U.S. patent application Ser. No. 14/173,359, is also aContinuation-in-Part Application of U.S. patent application Ser. No.13/332,896, filed Dec. 21, 2011 and entitled Devices, Methods andSystems for Wireless Control of Medical Devices, now U.S. PublicationNo. US-2012-0238851-A1, published Sep. 20, 2012, which is aContinuation-in-Part Application of U.S. patent application Ser. No.13/021,000, filed Feb. 4, 2011 and entitled Infusion Pump Apparatus,Method and System, now U.S. Publication No. US-2011-0319813-A1,published Dec. 29, 2011, which claims priority to U.S. ProvisionalApplication Ser. No. 61/301,957, filed Feb. 5, 2010 and entitledInfusion Pump Apparatus, Method and System, each of which is herebyincorporated herein by reference in their entireties.

TECHNICAL FIELD

The present disclosure relates to medical devices and more particularly,to a system for controlling at least one medical device.

BACKGROUND INFORMATION

Many potentially valuable medicines or compounds, including biologicals,are not orally active due to poor absorption, hepatic metabolism orother pharmacokinetic factors. Additionally, some therapeutic compounds,although they can be orally absorbed, are sometimes required to beadministered so often it is difficult for a patient to maintain thedesired schedule. In these cases, parenteral delivery is often employedor could be employed.

Effective parenteral routes of drug delivery, as well as other fluidsand compounds, such as subcutaneous injection, intramuscular injection,and intravenous (IV) administration include puncture of the skin with aneedle or stylet. Insulin is an example of a therapeutic fluid that isself-injected by millions of diabetic patients. Users of parenterallydelivered drugs may benefit from a wearable device that wouldautomatically deliver needed drugs/compounds over a period of time.

To this end, there have been efforts to design portable and wearabledevices for the controlled release of therapeutics. Such devices areknown to have a reservoir such as a cartridge, syringe, or bag, and tobe electronically controlled. These devices suffer from a number ofdrawbacks including the malfunction rate. Reducing the size, weight andcost of these devices is also an ongoing challenge. Additionally, thesedevices often apply to the skin and pose the challenge of frequentre-location for application.

Managing multiple medical devices simultaneously for a single userpresents challenges. One includes the hardware, for many medical devicesinclude a designated interface and with respect to medical devices thatare wirelessly controlled, multiple “controllers” or “hand helds”present logistical challenges. Firstly, the variety of interfaces may bedifficult to transfer attention from one to another and to master.Secondly, recharging multiple devices may present a challenge andthirdly, carrying the multiple controllers, together with the medicaldevices, presents challenges.

SUMMARY

In accordance with one aspect of the present invention, a medical devicesystem is disclosed. The system includes a first medical device, a firstremote interface, and a second remote interface in communication withthe first remote interface and the first medical device, wherein thefirst medical device sends a command to the first medical device throughthe second remote interface, and wherein when the second remoteinterface receives the command, the command must be confirmed by thesecond remote interface before the command is send by the second remoteinterface to the first medical device.

Some embodiments of this aspect of the invention may include one or moreof the following. Wherein the first medical device is an infusion pump.Wherein the first remote interface is a medical device data system.Wherein the second remote interface is not a medical device data system.Wherein the system further comprising a blood glucose meter incommunication with the second remote interface. Wherein the systemfurther comprising a continuous glucose monitor transmitter incommunication with the second remote interface. Wherein the first remoteinterface receives a command related to the communication of safetycritical information to the first medical device, displays a messagethat the communication of the safety critical information to the firstmedical device requires confirmation using the second remote interface,sends the communication to the second remote interface, and onceconfirmation received by the second remote interface, the second remoteinterface communicates the command to the first medical device. Whereinthe first remote interface receives an input of information related tothe delivery by the infusion pump of a bolus volume of infusible fluid,displays a message that the delivery of the bolus volume requiresconfirmation using the second remote interface, and once confirmationreceived by the second remote interface, the second remote interfacecommunicates the information required for the delivery of the bolusvolume of infusible fluid to the infusion pump.

In accordance with one aspect of the present invention, a medical devicesystem is disclosed. The medical device system includes a first medicaldevice, a first remote interface comprising a medical device datasystem, and a second remote interface in communication with the firstremote interface and the first medical device, wherein the first medicaldevice sends a safety critical command to the first medical devicethrough the second remote interface, and wherein when the second remoteinterface receives the safety critical command, the command must beconfirmed by the second remote interface before the safety criticalcommand is send by the second remote interface to the first medicaldevice.

Some embodiments of this aspect of the invention may include one or moreof the following. Wherein the first medical device is an infusion pump.Wherein the first remote interface is a medical device data system.Wherein the second remote interface is not a medical device data system.Wherein the system further comprising a blood glucose meter incommunication with the second remote interface. Wherein the systemfurther comprising a continuous glucose monitor transmitter incommunication with the second remote interface. Wherein the first remoteinterface receives an input of information related to the delivery bythe infusion pump of a bolus volume of infusible fluid, displays amessage that the delivery of the bolus volume requires confirmationusing the second remote interface; and once confirmation received by thesecond remote interface, the second remote interface communicates theinformation required for the delivery of the bolus volume of infusiblefluid to the infusion pump.

In accordance with one aspect of the present invention, a method ofcommunication for a medical system is disclosed. The method includes afirst remote interface receiving a command related to the communicationof safety critical information to a first medical device, the firstremote interface displaying a message that the communication of thesafety critical information to the first medical device requiresconfirmation using the second remote interface, the first remoteinterface sending the communication to the second remote interface, thesecond remote interface receiving confirmation, and the second remoteinterface communicating the command to the first medical device.

Some embodiments of this aspect of the invention may include one or moreof the following. Wherein the first medical device is an infusion pump.Wherein the command is related to the delivery of a bolus of infusiblefluid. Wherein the command is related to stopping the delivery of abasal rate of infusible fluid. Wherein the first remote interface is amedical device data system.

In accordance with one aspect of the present invention, a medical devicesystem is disclosed. The medical device system includes a first medicaldevice and a second medical device. The system also includes a remoteinterface including a touch screen. The remote interface is in wirelesscommunication with the first medical device and the second medicaldevice. The remote interface is configured to provide a user interfaceto the first medical device and the second medical device. The remoteinterface is configured to receive user input through a touch screen.Also, a charging device is included. The charging device is configuredto receive at least the first medical device and the remote interfaceand the charging device is configured to recharge a first medical devicebattery and the charging device is configured to recharge an interfacebattery in the remote interface. The charging device is connected to apersonal computer wherein the personal computer provides information tothe remote interface.

Some embodiments of this aspect of the invention may include one or moreof the following. Wherein the first medical device is an infusion pump;wherein the first medical device further includes at least onedisposable portion and at least two reusable portions, each of the tworeusable portions configured to connect to the at least one disposableportion; wherein the charging device is configured to receive at leastone of the at least two reusable portions of the first medical device;wherein the second medical device is a continuous glucose monitor systemcomprising at least one transmitter wherein the at least one transmitterin wireless communication with the remote interface; wherein the systemfurther includes a third medical device in wireless communication withthe remote interface; wherein the remote interface configured to providea user interface to the third medical device; wherein the third medicaldevice is at least one blood glucose meter; wherein the system furtherincludes wherein the wireless communication is radio frequencycommunication; wherein the first medical device and the remote interfaceare paired using near field communication; and/or wherein the remoteinterface further comprising at least one camera.

In accordance with one aspect of the present invention, a medical devicesystem is disclosed. The medical device system includes a first medicaldevice and a second medical device, in wireless communication with thefirst medical device. The system also includes a remote interfaceincluding a touch screen. The remote interface is in wirelesscommunication with the first medical device and the remote interface isconfigured to provide a user interface to the first medical device andthe second medical device. The remote interface is configured to receiveuser input through a touch screen. The system also includes a chargingdevice configured to receive the first medical device and the remoteinterface. The charging device configured to recharge a first medicaldevice battery, and the charging device is configured to recharge aninterface battery in the remote interface. The charging device isconnected to a personal computer wherein the personal computer providesinformation to the remote interface.

Some embodiments of this aspect of the invention may include one or moreof the following. Where the first medical device is an infusion pump;wherein the first medical device further includes at least onedisposable portion and at least two reusable portions, each of the tworeusable portions configured to connect to the at least one disposableportion; wherein the charging device configured to receive at least oneof the at least two reusable portions of the first medical device;wherein the second medical device including a continuous glucose monitorsystem including at least one transmitter wherein the at least onetransmitter in wireless communication with the first medical device;wherein the second medical device including a blood glucose meter inwireless communication with the first medical device; wherein the firstmedical device and the remote interface are paired using near fieldcommunication; wherein the first medical device and the second medicaldevice are paired using near field communication.

In accordance with one aspect of the present invention, an infusion pumpsystem is disclosed. The infusion pump system includes at least onedisposable portion of an infusion pump, at least two reusable portionsof an infusion pump, each of the two reusable portions of an infusionpump configured to connect to the at least one disposable portion. Thesystem also includes a remote interface including a touch screen, theremote interface in wireless communication with at least one of the atleast two reusable portions, the remote interface configured to provideuser instructions to the at least one of the at least two reusableportions, wherein the remote interface configured to receive user inputthrough a touch screen. The system also includes a charging deviceconfigured to receive at least one of the at least two reusable portionsand the remote interface. The charging device is configured to rechargea pump battery of the at least one of the at least two reusableportions, and the charging device is configured to recharge an interfacebattery in the remote interface. The charging device is connected to apersonal computer wherein the personal computer provides information tothe remote interface.

Some embodiments of this aspect of the invention may include one or moreof the following. Wherein the system further includes a continuousglucose monitor system including at least one transmitter wherein the atleast one transmitter in wireless communication with the remoteinterface; wherein the system further includes at least one bloodglucose meter wherein the blood glucose meter in wireless communicationwith the remote interface; wherein the at least one reusable portion andthe remote interface are paired using near field communication; whereinthe remote interface further including at least one accelerometer;wherein the remote interface further includes at least one camera.

In accordance with one aspect of the present invention, an infusion pumpsystem is disclosed. The infusion pump system includes an infusion pump,and a remote interface device in wireless communication with theinfusion pump including instructions for controlling the infusion pumpwherein the instructions may be synchronized with a secure web portal.

Some embodiments of this aspect of the invention may include one or moreof the following. Wherein the system further includes a continuousglucose monitor system including a transmitter wherein the transmitterin wireless communication with the remote interface device. Wherein thesystem further includes a blood glucose meter wherein the blood glucosemeter in wireless communication with the remote interface device.Wherein the wireless communication is radio frequency (“RF”)communication. Wherein the infusion pump and the remote interface deviceare paired using near field communication. Wherein the system furtherincludes at least one accelerometer.

In accordance with one aspect of the present invention, a medical devicesystem is disclosed. The medical device system includes a first medicaldevice and a second medical device in wireless communication with thefirst medical device, the second medical device including instructionsfor controlling the first medical device wherein the instructions may besynchronized with a secure web portal.

Some embodiments of this aspect of the invention may include one or moreof the following. Wherein the first medical device is an infusion pumpand the second medical device is a remote interface device. Wherein theinfusion pump and the remote interface device are paired using nearfield communication. Wherein the first medical device is a continuousglucose monitor sensor and the second medical device is a remoteinterface device. Wherein the infusion pump and the remote interfacedevice are paired using near field communication. Wherein the firstmedical device is a blood glucose meter and the second medical device isa remote interface device. Wherein the infusion pump and the remoteinterface device are paired using near field communication.

In accordance with one aspect of the present invention, a method forcommunication between two medical devices is disclosed. The methodincludes a first medical device sending a radio signal together with anacoustic signal to a second medical device, calculating the distancebetween the first medical device and the second medical device using theacoustic signal, determining whether the calculated distance exceeds apredetermined threshold, and if the calculated distance exceeds apredetermined threshold, notifying the user.

Some embodiments of this aspect of the invention may include one or moreof the following. Wherein the first medical device is a remote interfaceand the second medical device is an infusion pump. Wherein the firstmedical device is a remote interface and the second medical device is acontinuous glucose monitor sensor/transmitter. Wherein the first medicaldevice is a remote interface and the second medical device is a bloodglucose meter.

These aspects of the invention are not meant to be exclusive and otherfeatures, aspects, and advantages of the present invention will bereadily apparent to those of ordinary skill in the art when read inconjunction with the appended claims and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bebetter understood by reading the following detailed description, takentogether with the drawings wherein:

FIG. 1A is an exploded view of an embodiment of an infusion pump;

FIG. 1B is an exploded view of an embodiment of an infusion pump;

FIG. 2 is an exploded view of an embodiment of an infusion pump and asecond reusable portion;

FIG. 3 is a perspective view of one embodiment of the infusion pumpdisposable portion showing an external infusion set;

FIGS. 4A and 4B depict an embodiment of an infusion pump;

FIGS. 5A-5C depict an embodiment of an infusion pump;

FIG. 5D is an exploded view of an embodiment of a reusable portion;

FIG. 5E is an exploded view of an embodiment of a reusable portion;

FIG. 5F is an exploded view of an embodiment of a reusable portion;

FIGS. 5G-5I are views of an embodiment of a disposable portion;

FIG. 6 is a view of an embodiment of a remote interface;

FIGS. 7A and 7B are views of an embodiment of a remote interface;

FIG. 8 is a view of an embodiment of the system;

FIGS. 8B-8R depicts various views of high level schematics and flowcharts of an embodiment of the system;

FIG. 9A diagrammatically depicts an embodiment of a multi-processorcontrol configuration that may be included within one embodiment of thedevice;

FIG. 9B diagrammatically depicts an embodiment of a multi-processorcontrol configuration that may be included within one embodiment of thedevice in some embodiments;

FIGS. 10A and 10B diagrammatically depict one embodiment ofmulti-processor functionality;

FIG. 11 diagrammatically depicts one embodiment of multi-processorfunctionality;

FIG. 12 diagrammatically depicts one embodiment of multi-processorfunctionality;

FIGS. 12A-12E graphically depict various software layers according toone embodiment;

FIG. 13 is an illustration of one embodiment of the system;

FIGS. 14A-14E are illustrations of one embodiment of the system;

FIGS. 15A-15B are illustrations of one embodiment of a charging stationin one embodiment of the system;

FIGS. 16A-16F depict various views of an embodiment of a batterycharger/charging station according to one embodiment of the system;

FIG. 17 diagrammatically depicts one embodiment of an inter-connectionof the various elements of the system;

FIG. 18 is an illustration of one embodiment of the system;

FIG. 19 is an illustration of one embodiment of the system;

FIGS. 20A-30 are embodiments of various screen shots of a remoteinterface according to one embodiment of the system;

FIG. 31 is an embodiment of a 2D bar code;

FIG. 32 is an embodiment of a system for programming a basal profileusing the remote interface and a 2D bar code;

FIG. 33 is an embodiment of information that may be embedded in a 2D barcode;

FIG. 34 is an example of a basal profile that may be programmed into aremote interface using a camera;

FIG. 35A is an illustration of one embodiment of the system;

FIG. 35B is an illustration of one embodiment of the system;

FIG. 35C is an illustration of one embodiment of the system;

FIG. 35D is an illustration of one embodiment of the system;

FIG. 35E is an illustration of one embodiment of the system;

FIG. 36 is an illustration of one embodiment of the system;

FIG. 37 is an illustration of one embodiment of the system;

FIG. 38 is an illustration of one embodiment of the system;

FIG. 39 is an illustration of one embodiment of the system;

FIG. 40 is a flow chart of one method of the system according to oneembodiment;

FIG. 41 is a flow chart of one method of the system according to oneembodiment;

FIG. 42 is a flow chart of one method of the system according to oneembodiment;

FIGS. 43A-43O are embodiments of various screen shots of a mini-remoteinterface according to one embodiment of the system; and

FIGS. 44A-58T are embodiments of various screen shots of a remoteinterface according to one embodiment of the system.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Definitions

As used in this description and the accompanying claims, the followingterms shall have the meanings indicated, unless the context otherwiserequires:

A “remote interface” shall mean a device for wireless communication witha device which may include, but is not limited to, a medical device.

A “device” shall mean any medical device, which includes, but is notlimited to, a medical device, which includes, but is not limited to, aninfusion pump and/or a microinfusion pump, a drug delivery pump and/orapparatus, a sensor, a measuring device and/or meter, a blood pressuremonitor, ECG monitor, pill dispenser, pulse oximetry monitor, a CO2capometer, an intravenous bag, a drop-flow meter, a temperature monitor,a peritoneal dialysis machine, including, but not limited to, a homeperitoneal dialysis machine, a hemodialysis machine, including, but notlimited to, a home hemodialysis machine, and any other medical device ordevice configured to deliver, treat and/or determine medical care.

An “input” of a device includes any mechanism by which a user and/orother operator/caregiver of the device and/or remote interface maycontrol a function of the device and/or remote interface. User inputsmay include mechanical arrangements (e.g., switches, pushbuttons,jogwheel(s)), electrical arrangements (e.g., a slider, touch screen),wireless interfaces for communication with a remote interface (e.g.,radio frequency (“RF”), infrared (“IR”), BLUETOOTH), acoustic interfaces(e.g., with speech recognition), computer network interfaces (e.g., USBport), light/light wave image including, but not limited to, camerainput and/or images captured using a camera), sound wave and/or othertypes of interfaces.

A “button” in the context of an input such as the so-called “bolusbutton” discussed below may be any type of user input capable ofperforming a desired function, and is not limited to a pushbutton, aslider, switch, touch screen and/or a jog wheel.

An “alarm” includes any mechanism by which an alert may be generated toa user and/or third party/operator/caregiver. Alarms may include audiblealarms (e.g., a speaker, a buzzer, a speech generator), visual alarms(e.g., an LED, an LCD screen, an image), tactile alarms (e.g., avibrating element), wireless signals (e.g., a wireless transmission to aremote interface or caretaker), and/or other mechanism. Alarms may begenerated using multiple mechanisms simultaneously, concurrently, or ina sequence, including redundant mechanisms (e.g., two different audioalarms) or complementary mechanisms (e.g., an audio alarm, a tactilealarm, and a wireless alarm) and/or mechanisms of increasing volumeand/or intensity (e.g. escalating alarm sequence).

“Fluid” shall mean a substance, e.g., a liquid, capable of flowingthrough a flow line or fluid line.

A “user” includes a person or animal receiving treatment from orconnected to the device whether as part of a medical treatment orotherwise and/or a caregiver or third party involved in programming thedevice or otherwise interacting with the device to convey treatment andor collect information from the device, which may include, but is notlimited to, a physician and/or medical provider and/or companion and/orparent and/or guardian.

“Cannula” shall mean a disposable device capable of infusing fluid to auser. A cannula as used herein may refer to a traditionalcannula/flexible tube or to a needle.

“Disposable” refers to a part, device, portion or other that is intendedto be used for a fixed duration of time, then discarded and replaced.

“Reusable” refers to a portion that is intended to have an open-endedduration of use.

“Acoustic volume measurement” shall mean quantitative measurement of arelevant volume using acoustical techniques such as those described inU.S. Pat. Nos. 5,349,852 and 5,641,892, and in U.S. patent applicationSer. No. 11/704,899, filed Feb. 9, 2007 and entitled Fluid DeliverySystems and Methods, now U.S. Publication No. US-2007-0228071-A1published Oct. 4, 2007, and U.S. patent application Ser. No. 12/347,985,filed Dec. 31, 2008, and entitled Infusion Pump Assembly, now U.S.Publication No. US-2009-0299277 published Dec. 3, 2009, which are eachhereby incorporated herein by reference in their entireties, as well asother techniques.

An exemplary use of various embodiments of the devices, methods andsystems described here is for the delivery of insulin to people livingwith diabetes, but other uses include delivery of any fluid, sensing ofany condition and/or state and/or providing medical treatment and/ormedical care. Fluids may include, but are not limited to, analgesics tothose in pain, chemotherapy to cancer patients and enzymes to patientswith metabolic disorders. Various therapeutic fluids may include, butare not limited to, small molecules, natural products, peptide,proteins, nucleic acids, carbohydrates, nanoparticulate suspensions, andassociated pharmaceutically acceptable carrier molecules.Therapeutically active molecules may be modified to improve stability inthe device (e.g., by pegylation of peptides or proteins). Althoughillustrative embodiments herein describe drug-delivery applications,embodiments may be used for other applications including liquiddispensing of reagents for high throughput analytical measurements suchas lab-on-chip applications and capillary chromatography. For purposesof description below, terms “therapeutic”, “insulin” or “fluid” are usedinterchangeably, however, in other embodiments, any fluid, as describedabove, may be used. Thus, the devices, systems, methods and descriptionthereof included herein are not limited to use with therapeutics.

Some embodiments of the device are adapted for use by people living withdiabetes and/or their caregivers. Thus, in these embodiments, thedevices, methods and systems work to deliver insulin which supplementsor replaces the action of the person living with diabetes' (referred toas the user) pancreatic islet beta cells. Embodiments adapted forinsulin delivery seek to replace the action of the pancreatic islet betacells by providing both a basal level of fluid delivery as well as boluslevels of fluid delivery. Basal levels, bolus levels and timing may beset by the user by using a remote interface user interface or directlyby using a user interface on the device. Additionally, basal and/orbolus levels may be triggered or adjusted in response to the output ofone or more glucose meters and/or glucose monitors (i.e., devices)which, in the exemplary embodiments, may be integral to, or in wirelesscommunication with, the remote interface. In other embodiments, theremote interface may include one or more analyte monitoring deviceswhich may include, but is not limited to, a blood glucose meter/devicewhich receives blood samples and/or receives a device that is configuredto receive a blood sample, e.g., a blood glucose strip. In someembodiments, a bolus may be triggered by a user using a designatedbutton or other input means located on a device, i.e., on an infusionpump, and/or on a remote interface. In still other embodiments, thebolus or basal may be programmed or administered through a userinterface located either on the device (e.g., on the infusion pumpand/or on the remote interface).

With respect to the names given to screens and types of screens herein,as well as proper names given to various features, throughout variousembodiments, these terms may vary and are for descriptive purposes. Thedescription is not limited by these names.

The devices, systems and methods described herein may be used to controlan infusion pump. For purposes of this description, the variousembodiments of the user interface and the infusion pump may be describedwith reference to an insulin pump, or a pump which infuses insulin.However, it should be understood that the user interface may be on aninfusion pump and/or on a remote interface and the medical device towhich the remote interface communicates with may be any medical device,i.e., is not limited to an infusion pump. Additionally, where thedescription pertains to an infusion pump “screen”, this “screen” mayalso appear on a remote interface, or may appear on a remote interfacein lieu of on an infusion pump.

Infusion pumps contemplated by this description include a pump which maypump any fluid, including, but not limited to, a therapeutic fluid,which includes, but is not limited to, insulin. Thus, where thisdescription describes an embodiment as pertaining to insulin, this ismeant merely for descriptive purpose only, as the device is not intendedto be limited to insulin. Other fluids are also contemplated. In someembodiments, the methods, systems and devices described herein may beused in conjunction with other fluid delivery devices, e.g., pens and/orsyringes, which are known in the art.

The system for controlling a device described herein may be used for anyone or more device, and in some embodiments, the device may include aninfusion pump and/or an infusion pump system which may deliver fluidand/or may be configured to deliver fluid to a user through a cannula.For descriptive purposes only, an infusion pump system, which mayinclude at least one insulin pump, is described herein. However, thesystem is not limited to use with one or more infusion pumps and/or aninsulin pump systems, rather, may be used with any device and/or withany one or more devices.

Referring now to FIGS. 1A and 1B, one embodiment of a device 100 isshown. The device 100, in the illustrative embodiment, is an infusionpump, which may be any infusion pump, however, in some embodiments, maybe one of the embodiments of the infusion pumps shown and described inU.S. Publication No. US-2007-0228071, published Oct. 4, 2007 (E70) orU.S. Publication No. US-2009-0299277-A1 published Dec. 3, 2009. However,and as discussed above, in various other embodiments, the device may beany medical device and in some embodiments, one or more devices areincluded in a system.

The device 100 includes a reusable portion 102 and a disposable portion104. In various embodiments, disposable portion 104 includes a reservoirand a fluid line, i.e., the “wetted” components of an infusion pump. Insome embodiments, the disposable portion 104 includes a tab 116.

The reusable portion 102 includes mechanical and electrical components108 configured to cause fluid in the reservoir to be pumped from thereservoir to the tubing 106 which may be connected to a cannula (notshown, shown in FIG. 3 as 308). In some embodiments, the reusableportion 102 may include a locking ring assembly 110 and a position nub808 that may facilitate rotation of the locking ring assembly 110. Thereusable portion 102 may be releasably engaged to the disposable portion104 which may be effectuated by, for example, but not limited to, ascrew-on, twist-lock, or compression fit configuration, or otherconfiguration. In some embodiments, the reusable portion 104 may beproperly positioned relative to the disposable portion 102, and lockingring assembly 110 may be rotated to releasable engage the reusableportion 104 to the disposable portion 102.

Additionally, the position of nub 112, e.g., relative to tab 116 ofdisposable housing assembly 104, may provide verification that thereusable portion 102 is fully engaged with the disposable portion 104.For example, as shown in FIG. 4A, when the reusable portion 402 isproperly aligned with the disposable portion 104, the nub 412 may bealigned in a first position, relative to the tab 416. Upon achieving afully engaged condition, by rotation of the locking ring assembly 410(direction of rotation shown by arrow in FIG. 4A), the nub 412 may bealigned in a second position relative to the tab 416, as shown in FIG.4B.

Referring now also to FIG. 2 , in some embodiments of the system, thesystem may include one or more devices, and in some embodiments, thesystem may include two devices 200, 202. In some embodiments of thesystem, the system may include two reusable portions 200, 202 and atleast one disposable portion 204. The reusable portions 200, 202 and thedisposable portion 204 may be, in some embodiments, the embodiments ofthe device 100 described above. In some embodiments of the system, thesystem may include two reusable portions 200, 202 that may each includerechargeable power device, e.g., a rechargeable battery. Therefore, insome embodiments, while one reusable portion 200 is connected to adisposable portion 204 and in use by a user, the other reusable portion202 may be recharged. Thus, in some embodiments, the system may includea backup device that may be recharged or serviced while the other deviceis in use.

Referring also to FIG. 3 , in some embodiments, the disposable portion300 includes a tubing 302 which may include a male connector 304connected to the tubing 302. The male connector 304, in someembodiments, is configured to be connected to a female connector 306.The completed connection of the male connector 304 to the femaleconnector 306 provides a fluid pathway from the tubing 302 to thecannula 308 and therefore from the reservoir to the cannula. The cannula308 may be held in place on a user by a cannula adhesive pad 310. Thetubing 302, male connector 304, female connector 306, cannula 308 andcannula adhesive pad 310 may collectively be referred to as an infusionset 312. In some embodiments, the reusable portion 300 may be held ontoa user by a patch 314 which may, in some embodiments, may be adisposable adhesive patch (connected to the lower surface of thedisposable portion 300 and the adhesive may be exposed and then attachedto a user) or a hook and loop fastener patch, for example. Inembodiments where the disposable patch is a loop and hook fastener patch(e.g. such as hook and loop fastener systems offered by VELCRO USA Inc.of Manchester, N.H.) the lower surface of the disposable portion 300 mayinclude a complementary hook or loop surface.

Referring now also to FIGS. 5A-5F, in some embodiments, the reusableportion 500 may include an input switch assembly that may be configuredto receive user commands (e.g., for bolus delivery, pairing with aremote interface, or the like). The input switch assembly, in someembodiments, may include a button 824 that may be disposed in an opening526 of the body 520. As shown, e.g., in FIG. 5B, the locking ringassembly 506 may include a radial slot 528 that may be configured toallow the locking ring assembly 506 to be rotated relative to body 520while still providing facile access to the button 524.

Still referring to FIGS. 5A-5F, electrical control assembly 516 mayinclude printed circuit board 530 as well as battery 532, which in someembodiments may be a rechargeable battery. The printed circuit board 530may include the various control electronics for monitoring andcontrolling the amount of infusible fluid that has been and/or is beingpumped. For example, the electrical control assembly 516 may measure theamount of infusible fluid that has just been dispensed, and determine,based upon the dosage required by the user, whether enough infusiblefluid has been dispensed. If not enough infusible fluid has beendispensed, the electrical control assembly 516 may determine that moreinfusible fluid should be pumped. The electrical control assembly 516may provide the appropriate signal to the mechanical control assembly512 so that any additional necessary dosage may be pumped or theelectrical control assembly 516 may provide the appropriate signal tothe mechanical control assembly 512 so that the additional dosage may bedispensed with the next dosage. Alternatively, if too much infusiblefluid has been dispensed, the electrical control assembly 516 mayprovide the appropriate signal to the mechanical control assembly 512 sothat less infusible fluid may be dispensed in the next dosage. Theelectrical control assembly 516 may include one or more microprocessors.In an exemplary embodiment, the electrical control assembly 516 mayinclude three microprocessors. One processor (e.g., which may include,but is not limited to a CC2510 microcontroller/radio frequency (“RF”)transceiver, available from Chipcon AS, of Oslo, Norway) may bededicated to radio communication, e.g., for communicating with a remoteinterface. Two additional microprocessors (example of which may include,but is not limited to an MSP430 microremote interface, available fromTexas Instruments Inc. of Dallas, Tex.) may be dedicated to issuing andcarrying out commands (e.g., to dispense a dosage of infusible fluid,process feedback signals from a volume measurement device, and thelike).

As shown in FIG. 5C, base plate 518 may provide access to the electricalcontacts 534, e.g., which may be electrically coupled to the electricalcontrol assembly 516 for rechargeable battery 532. The base plate 518may include one or more features (e.g., openings 536, 538) which may beconfigured to facilitate proper alignment with the disposable housingassembly 504 by way of cooperating features (e.g., tabs) of thedisposable housing assembly 504. Additionally, base plate 518 mayinclude various features for mounting a valve assembly 514 and theelectrical control assembly 516, as well as providing access to thedisposable portion 504 by valve assembly 514 (shown in FIGS. 5D-5F).

The locking ring assembly 506 may include grip inserts 540, 542, e.g.,which may include an elastomeric or textured material that mayfacilitate gripping and twisting the locking ring assembly 506, e.g.,for engaging/disengaging the reusable portion 500 and the disposableportion 504. Additionally, the locking ring assembly 506 may include oneor more sensing components, which in some embodiments may be a magnet544, but in other embodiments may be an electrical contact or othersensing component. In various embodiments, the sensing component mayinteract with one or more components of the reusable portion 500 (e.g.,a Hall Effect sensor), e.g., to provide an indication of the nature of amating component (e.g., which in some embodiments may include, but isnot limited to, one or more of the disposable portion 504, a chargingstation, or a filling station) and/or of whether the reusable portion500 is properly engaged with the mating component. In some embodiments,a Hall Effect sensor (not shown) may be located on the pump printedcircuit board 530. The Hall Effect sensor may detect when the lockingring assembly 506 has been rotated to a closed position. Thus, in someembodiments, the Hall Effect sensor together with the magnet 544 mayprovide a system for determining whether the locking ring assembly 506has been rotated to a closed position.

The sensing component (magnet) 544 together with the reusable portioncomponents, i.e., in the some embodiments, the Hall Effect sensor, maywork to provide for a determination of whether the reusable portion 500is properly attached to the intended component or device. In someembodiments, the locking ring assembly 506 may not turn without beingattached to a component, which may include, but is not limited to, adisposable portion 504, a dust cover (not shown) or a battery charger(not shown). Thus, the sensing component 544 together with the reusableportion 500 may function to provide many advantageous safety features tothe infusion pump system. These features may include, but are notlimited to, one or more of the following. Where the system does notdetect being attached to a disposable portion 504, a dust cover or acharger, the system may notify, alert or alarm the user as the reusableportion 500, e.g., the valves and pumping components, may be vulnerableto contamination or destruction which may compromise the integrity ofthe reusable assembly. Thus, the system may provide for an integrityalarm to alert the user of potential reusable integrity threats. Also,where the system senses the reusable assembly is attached to a dustcover, the system may power off or reduce power to conserve power. Thismay provide for more efficient use of power where the reusable portionis not connecting to a component in which it needs to interact.

The reusable portion 500 may attach to a number of different components,including but not limited to, a disposable housing assembly, a dustcover or a battery charger/battery charging station. In each case, theHall Effect sensor may detect that the locking ring assembly 506 is inthe closed position, and therefore, that reusable portion 500 isreleasably engaged to a disposable portion 504, a dust cover, or abattery charger/battery charging station (or, another component invarious embodiments). The infusion pump system may determine thecomponent to which it is attached by using an AVS system, such as onedescribed in the above referenced patent publications and patents, or byan electronic contact. Referring now also to FIGS. 5G-5I, one embodimentof a dust cover (e.g., dust cover 539) is shown. In the exemplaryembodiment, dust cover 539 may include features 541, 543, 545, 547 suchthat the locking ring assembly 506 of the reusable portion 500 mayreleasably engage the dust cover 539. In addition, the dust cover 539may further include a recess region 5849 for accommodating the valvingand pumping features of reusable portion 500. For example, with respectto the dust cover, the AVS system may determine that a dust cover, andnot a disposable portion, is connected to the reusable portion. The AVSsystem may distinguish using a look-up table or other comparative dataand comparing the measurement data with characteristic dust cover orempty disposable portion data. With respect to the battery charger, thebattery charger, in some embodiments, may include electric contacts.When the reusable portion is attached to the battery charger, theinfusion pump assembly electronic system may sense that the contactshave been made, and will thus indicate that the reusable portion isattached to a battery charger.

Various embodiments of the infusion pump may include, or be similar to,a reservoir assembly configured to contain infusible fluid. In someembodiments, reservoir assembly may be a reservoir assembly similar tothat described in U.S. Pat. No. 7,498,563, issued Mar. 3, 2009 andentitled Optical Displacement Sensor for Infusion Devices, which isherein incorporated by reference in its entirety; and/or as described inU.S. Pat. No. 7,306,578, issued Dec. 11, 2007 and entitled LoadingMechanism for Infusion Pump; PCT Application Serial No.PCT/US2009/060158, filed Oct. 9, 2009 and entitled Infusion PumpAssembly, now Publication No. WO 2010/042814, published Apr. 15, 2010;and/or U.S. patent application Ser. No. 12/249,882, filed Oct. 10, 2008and entitled Infusion Pump Assembly, now U.S. Publication No.US-2010-0094222, published Apr. 15, 2010; and/or U.S. patent applicationSer. No. 13/076,067, filed Mar. 30, 2011 and entitled Infusion PumpMethods, Systems and Apparatus, now U.S. Publication No.US-2011-0230837, published Sep. 22, 2011; and/or U.S. patent applicationSer. No. 13/121,822, filed Mar. 30, 2011 and entitled Infusion PumpAssembly, now U.S. Publication No. US-2011-0208123, published Aug. 25,2011; all of which are hereby incorporated herein by reference in theirentireties.

In some embodiments, the various embodiments of the infusion pump mayinclude or be similar to one or more described in U.S. Pat. No.7,306,578, issued Dec. 11, 2007 and entitled Loading Mechanism forInfusion Pump; U.S. patent application Ser. No. 12/249,882, filed Oct.10, 2008 and entitled Infusion Pump Assembly, now U.S. Publication No.US-2010-0094222, published Apr. 15, 2010; and U.S. patent applicationSer. No. 12/249,891, filed Oct. 10, 2008 and entitled Infusion PumpAssembly, now U.S. Publication No. US-2009-0099523 published Apr. 16,2009, all of which are hereby incorporated herein by reference in theirentireties.

In some embodiments, the device, which may be in some embodiments, aninfusion pump such as one described above, includes hardware forwireless radio frequency (“RF”) communication with a remote interface.However, in various embodiments, the device may be any device and is notlimited to an infusion pump. In some exemplary embodiments of thesystem, the device may include a display assembly, which may include,but is not limited to, one or more of the following: at least one screenor other display including a visual indication to a user; however, inother embodiments, such as those shown in FIGS. 1A-5F, the device maynot include a display assembly. In these embodiments, a display assemblymay be included on a remote interface. In some embodiments of thesystem, even if the device includes a display, the system may include aremote interface that also includes a display. Some embodiments of aremote interface are shown in FIGS. 6, 7, 7A and 8 .

Referring to the infusion pump system shown in FIGS. 1A-5I, but also toother devices that may be used with the system, the device may includeprocessing logic (not shown), which may be referred to as one or moreprocessors, that execute one or more processes that may be required forthe device to operate. Processing logic may include one or moremicroprocessors (not shown), one or more input/output remote interfaces(not shown), and cache memory devices (not shown). One or more databuses and/or memory buses may be used to interconnect processing logicwith one or more subsystems.

Where the system requires an interaction between the user and thedevice, the interaction may be accomplished using an input either on theremote interface or on the device, for example, in some embodiments,where the device is an infusion pump, the input on the device may be theswitch assembly on the infusion pump.

Processing logic, in some embodiments, is used to receive inputs from auser. The user may use one or more input devices or assemblies,including but not limited to, one or more of the following:button/switch assembly, slider assemblies, including, but not limitedto, capacitive sliders (which may include, for example, including butnot limited to any slider described in U.S. patent application Ser. No.11/999,268, filed Dec. 4, 2007 and entitled Medical Device Including aSlider Assembly, now U.S. Publication No. US-2008-0177900, publishedJul. 24, 2008, which is hereby incorporated herein by reference in itsentirety, jog wheel, audio input, tactile input and/or touch screen. Insome embodiments, the device may additionally receive inputs frominternal systems. These internal systems may include, for example, inembodiments where the device is an infusion pump, these may include, butare not limited to, one or more of the following: occlusion detectionprocesses, confirmation processes, and volume measurement technology,e.g., acoustic volume sensing (“AVS”). Using these inputs, the device,which, in some embodiments may be an infusion pump, may produce outputs,for example including, but not limited to, infusion fluid delivery tothe user; and/or these inputs may produce outputs that may include, butare not limited to, one or more of the following: comments, alerts,alarms or warnings to the user. The inputs are thus either directly fromthe user to the device, directly from the device systems to theprocessing logic, or from another device or remote interface, to thedevice. The user interaction experience thus includes, but is notlimited to, one or more of the following: interaction with a display(either on the device itself or a remote interface or both), whichincludes but is not limited to, reading/seeing text and/or graphics on adisplay, direct interaction with a display, for example, through a touchscreen, interaction with one or more buttons, sliders, jog wheels orother inputs, interaction with one or more glucose strip readers, andsensing either through touch sensation or audio, one or more vibrationmotors, and/or an audio system. Thus, the term “user interface” is usedto encompass all of the systems, methods and devices in which a useruses to interact with the device to control and/or receive informationfrom the device.

Referring now to FIGS. 6 and 7A-7B, in some embodiments of the infusionpump system, the infusion pump may be remotely controlled using a remoteinterface 600, 700. Two embodiments of the remote interface are shown,however, in various other embodiments, the remote interface may be anytype of device that is capable of interaction with a device, includingby way of wireless and/or remote communication. The remote interface600, 700 may include all, or a portion of, the functionality of thedevice, which, in some embodiments, may include an infusion pump similarto one shown and described herein with respect to FIGS. 1A-5I. Asdiscussed above, for purposes of description, the device may bedescribed as an infusion pump, however, this disclosure is not limitedto an infusion pump. Also, the systems, methods and apparatus describedherein may be used with any device.

In some embodiments of the above-described infusion pump, the infusionpump may be configured using a remote interface 600, 700. In theseembodiments, the infusion pump may include telemetry circuitry (notshown) that allows for communication (e.g., wired or wireless) betweenthe infusion pump and the remote interface 600, 700, thus allowing theremote interface 600, 700 to remotely control the infusion pump. Theremote interface 600, 700 (which may also include telemetry circuitry(not shown) and may be capable of communicating with infusion pump) mayinclude a display assembly 602, 702 and at least one input assembly,which may include one or more of the following: an input control device(such as jog wheel 606, slider assembly 610, or another conventionalmode for input into a device), and/or switch assemblies 604, 608, 704.Thus, although the remote interface 600 as shown in FIG. 6 includes ajog wheel 606 and slider assembly 610, some embodiments may include onlyone of either the jog wheel 606 or the slider assembly 610, or anotherconventional mode for input into a device. In embodiments having a jogwheel 606, the jog wheel 606 may include a wheel, ring, knob, or thelike, that may be coupled to a rotary encoder, or other rotarytransducer, for providing a control signal based upon, at least in part,movement of the wheel, ring, knob, or the like.

In some embodiments, the remote interface may include a touch screen andin such embodiments, as depicted in FIGS. 7A and 7B, the touch screenmay include one or more icons 706, 710 indicating functions of theremote interface 700. In some embodiments, one or more the icons 706,710 may relate to launching applications configured to communicate witha device. As shown in FIG. 7A, in some embodiments, one or more icons706 may indicate one or more devices, which, in some embodiments, may bemedical devices (e.g., medical device 1, medical device 2, medicaldevice 3) applications. However, in various embodiments, less than ormore than three icons 706 may be included on the remote interface 700.Also, as shown in FIG. 7A, in some embodiments, the remote interface 700may include icons 710 relating to launching applications related toanother functionality of the remote interface 700 (in addition tocommunicating with at least one device). In some embodiments, these mayinclude, but are not limited to, launching a web browser, launching acell phone or mobile phone functionality and/or launching an MP3 orother “audio” player functionality. In some embodiments, it may bedesirable for the user to “launch” the various functions and/orapplications of the remote interface 700. In some embodiments, thenon-device related functionalities may be dormant and/or may “sleep”until and unless launched. This may be desirable for many reasons,including, but not limited to, extending the battery life and/orpreventing distraction and/or slowing performance with respect to use ofthe remote interface 700 to communicate with one or more devices. Insome embodiments, once a device is paired with the remote interface 700(as described in more detail below), the application may beautomatically launched. In some embodiments, the icons 706 with respectto the devices on the remote interface 700 may indicate that the“application” is “minimized” in the display 702, but the application isactive. Thus, in some embodiments, launching of the applications relatedto the devices using the icons 706 may not be necessary and may beautomatic once the remote interface 700 is paired with the device.Referring to FIG. 7B, in some embodiments, the remote interface 700 mayinclude various buttons on the display assembly that are links to addnotes and or tags to a logbook. Thus, in some embodiments, when the usertaps one of the buttons, a note may open and the user may add a note tothe logbook. In some embodiments, tapping the icon may automaticallyregister that event in the logbook.

The various embodiments of the remote interface may include the abilityto pre-program basal rates, bolus alarms, delivery limitations, userprofiles, etc., and allow the user to view history, logbook, etc and toestablish user preferences. In some embodiments, the remote interfacemay also include a glucose strip reader. However, in variousembodiments, where the remote interface does not communicate with aninfusion pump, but rather, other devices, the abilities of the remoteinterface may vary.

During use, in some embodiments, the remote interface 600, 700 maycommunicate with the infusion pump assembly using a wirelesscommunication channel established between remote interface 600, 700 andthe infusion pump. Accordingly, the user may use the remote interface600,700 to program/configure the infusion pump. In some embodiments,some or all of the communication between remote interface 600, 700 andthe infusion pump may be encrypted to provide an enhanced level ofsecurity.

In various embodiments of the user interface, the user interface mayrequire user confirmation and/or user input. In some embodiments, theuser interface is centered on ensuring the user knows the effect ofvarious interactions with the device. Many examples will be presentedthroughout this description of the device communicating the result ofthe user's actions to the user. These features ensure the userunderstands their actions and therefore, imparts greater safety onto theuser. One such example is where a user presses the back button on ascreen after a value has been changed; the user interface displays a“Cancel Changes?” confirmation screen. If the user selects “Yes”, invarious embodiments the user interface discards any pending changes,closes the confirmation screen and goes back to the previous screen(i.e., the screen previous to the screen where the user pressed the Backbutton). When the action selection is “No”, on the “Cancel Changes?”confirmation screen, the user presses the enter button or otherdepending on the embodiment, and the user interface closes theconfirmation screen and returns to the screen with pending changes. Thisfeature prevents the outcome where the user assumes the changes havebeen implemented, but in fact, they have not been. Thus, this featureprevents that circumstance and ensures the user understands that thechanges have not been implemented. This is just one of many examples ofthe user interface requiring user confirmation and/or input.

Additionally and referring also to FIG. 8 , in some embodiments of thedevice, the device 800 may be configured by a remote interface 802. Insome embodiments, the device 800 may include telemetry circuitry (notshown) that allows for communication (e.g., wired or wireless) betweenthe device 800 and at least one remote interface 802, thus allowing theremote interface 802 to remotely communicate with the device 800. Theremote interface 802 (which may also include telemetry circuitry (notshown) and may be capable of communicating with the device 800 mayinclude, in various embodiments, a display assembly 804 and at least oneinput assembly 806. The input assembly 806 may include at least oneswitch assembly in some embodiments and in some embodiments may include,but are not limited to, any of one or more of the input assembliesdescribed above. Thus, in some embodiments, the input assembly mayinclude a jog wheel, a plurality of switch assemblies, a capacitiveslider or the like.

The remote interface 802 may include the ability to command the deviceand/or to receive information from the device. In some embodiments, theremote interface 802 may include the ability to view history, receiveand view alarms, program limitations, for example, delivery limitations,and/or establish user preferences. In some embodiments, the remoteinterface 802 may allow the user to view the status of the device whichmay include the power status, delivery status, values read, alarmstatus, progress of the device, and/or any other data that may becommunicated from the device to the remote interface 802. In someembodiments, the remote interface 802 may include a glucose strip readerand/or a temperature indication device and or other medicalfunctionalities that may be desired to treat and/or to diagnose and/orto provide a medical service to the user.

In some embodiments, the remote interface 802 may provide instructionsto the device 800 by way of a wireless communication channel 808established between the remote interface 802 and the device 800.Accordingly, the user may use remote interface 802 to program/configurethe device 800. Some or all of the communication between remoteinterface 802 and the device may be encrypted to provide an enhancedlevel of security.

Communication between the remote interface 802 and the device 800 may beaccomplished utilizing a standardized communication protocol. Further,communication between the various components included the device 800 maybe accomplished using the same protocol. One example of such acommunication protocol is the Packet Communication Gateway Protocol(PCGP) developed by DEKA Research & Development of Manchester, N.H. Asdiscussed above, the device 800, which, in some embodiments may be aninfusion pump, may include an electrical control assembly 516 that mayinclude one or more electrical components. For example, electricalcontrol assembly 516 may include a plurality of data processors (e.g. asupervisor processor and a command processor) and a radio processor forallowing the device 800 to communicate with the remote interface 802.Further, the remote interface 802 may include one or more electricalcomponents, examples of which may include but are not limited to acommand processor and a radio processor for allowing the remoteinterface 802 to communicate with the device 800. A high-leveldiagrammatic view of one example of such a system is shown in FIG. 8B.

Each of these electrical components may be manufactured from a differentcomponent provider and, therefore, may utilize native (i.e. unique)communication commands. Accordingly, through the use of a standardizedcommunication protocol, efficient communication between such disparatecomponents may be accomplished.

PCGP may be a flexible extendable software module that may be used onthe processors within the device 800 and the remote interface 802 tobuild and route packets. PCGP may abstract the various interfaces andmay provide a unified application programming interface (API) to thevarious applications being executed on each processor. PCGP may alsoprovide an adaptable interface to the various drivers. For illustrativepurposes only, PCGP may have the conceptual structure illustrated inFIG. 8C for any given processor.

PCGP may ensure data integrity by utilizing cyclic redundancy checks(CRCs). PCGP may also provide guaranteed delivery status. As a nonlimiting example, all new messages should have a reply. If such a replyis not sent back in time, the message may time out and PCGP may generatea negative acknowledge reply message for the application (i.e., a NACK).Accordingly, the message-reply protocol may let the application knowwhether the application should retry sending a message.

In some embodiments, PCGP may also limit the number of messagesin-flight from a given node, and may be coupled with a flow-controlmechanism at the driver level to provide a deterministic approach tomessage delivery and may let individual nodes have different quantitiesof buffers without dropping packets. As a node runs out of buffers,drivers may provide back pressure to other nodes and prevent sending ofnew messages.

PCGP may use a shared buffer pool strategy to minimize data copies, andmay avoid mutual exclusions, which may have a small affect on the APIused to send/receive messages to the application, and a larger affect onthe drivers. PCGP may use a “Bridge” base class that provides routingand buffer ownership. The main PCGP class may be sub-classed from thebridge base class. In some embodiments, drivers may be derived from abridge class, or talk to or own a derived bridge class.

In some embodiments, PCGP may be designed to work in an embeddedenvironment with or without an operating system by using a semaphore toprotect shared data such that some calls can be re-entrant and run on amultiple threads. One non-limiting illustrative example of such animplementation is shown in FIG. 8D. PCGP may operate the same way inboth environments, but there may be versions of the call for specificprocessor types (e.g., the ARM 9/OS version). So while the functionalitymay be the same, in some embodiments, there may be an operating systemabstraction layer with slightly different calls tailored for e.g., theARM 9 Nucleus OS environment.

Referring also to FIG. 8E, PCGP may:

-   -   allow multiple Send/Reply calls to occur’;    -   have multiple drivers running asynchronously for RX and TX on        different interfaces; and/or    -   provide packet ordering for send/receive, and deterministic        timeout on message send.

In some embodiments, each software object may ask the buffer manager forthe next buffer to use, and may then give that buffer to another object.Buffers may pass from one exclusive owner to another autonomicly, andqueues may occur automatically by ordering buffers by sequence number.In some embodiments, when a buffer is no longer in use, the buffer maybe recycled (e.g., object attempts to give the buffer to itself, orfrees it for the buffer manager to re-allocate later). Accordingly, insome embodiments, data generally does not need to be copied, and routingsimply writes over the buffer ownership byte.

Such an implementation of PCGP may provide various benefits, examples ofwhich may include, but are not limited to:

-   -   dropping a message due to lack of buffers may be impossible, as        once a message is put into a buffer, the message may live there        until it is transferred or received by the application;    -   data may not need to be copied, as offsets are used to access        driver, PCGP and payload sections of a buffer;    -   drivers may exchange ownership of message data by writing over        one byte (i.e., the buffer ownership byte);    -   there may be no need for multiple exclusions except for        re-entrant calls, as a mutual exclusion may be needed only when        a single buffer owner could simultaneously want to use a buffer        or get a new sequence number;    -   there may be fewer rules for application writers to follow to        implement a reliable system;    -   drivers may use ISR/push/pull and polled data models, as there        are a set of calls provided to push/pull data out of the buffer        management system from the drivers;    -   drivers may not do much work beyond TX and RX, as drivers may        not copy, CRC or check anything but the destination byte and CRC        and other checks may be done off of the ISR hot path later;    -   as the buffer manager may order access by sequence number, queue        ordering may automatically occur; and    -   a small code/variable foot print may be utilized; hot path code        may be small and overhead may be low.

As shown in FIG. 8F, when a message needs to be sent, the PCGP may buildthe packet quickly and may insert it into the buffer management system.Once in the buffer management system, a call to “packetProcessor” mayapply protocol rules and may give the messages to thedrivers/application.

To send a new message or send a reply, PCGP may perform one or more ofthe following:

-   -   check the call arguments to e.g., make sure the packet length is        legal, destination is ok, etc.;    -   avoid trying to send a message across a link that is down unless        the down link is the radio node, which may allow PCGP to be used        by the radio processors to establish a link, pair, etc. and, in        some embodiments, may notify the application when PCGP is trying        to talk across a link that is not functional (instead of timing        out);    -   obtain a sequence number for a new message or utilize an        existing sequence number for an existing message;    -   build the packet, copy the payload data and write in the CRC,        wherein (from this point forward) the packet integrity may be        protected by the CRC; and/or    -   either give the message to the buffer manager as a reply or as a        new message, and check to see if putting this buffer into the        buffer manager would exceed the maximum number of en-queued send        messages.

Referring also to FIGS. 8G-8H, in some embodiments, PCGP may work bydoing all of the main work on one thread to avoid mutual exclusions, andto avoid doing considerable work on the send/reply or driver calls. The“packetProcessor” call may have to apply protocol rules to replies, newsent messages, and received messages. Reply messages may simply getrouted, but new messages and received messages may have rules forrouting the messages. In each case, the software may loop while amessage of the right type is available to apply protocol rules until itcannot process the packets.

Sending a new message may, in some embodiments, conform to one or moreof the following rules:

-   -   only two messages may be allowed “in-flight” on the network;        and/or    -   enough data about an in-flight message may be stored to match        the response and handle timeout.

Receiving a message may conform to the following rules:

-   -   responses that match may clear out the “in-flight” information        slot so a new packet may be sent;    -   responses that do not match may be dropped;    -   new messages may be for the protocol (e.g., getting/clearing        network statistics for this node);    -   to receive a message, the buffer may be given up to the        application and may use a call back; and/or    -   the buffer may be freed or left owned by the application.

Accordingly, in some embodiments, PCGP may be configured such that:

-   -   the call back function may copy the payload data out or may use        it completely before returning;    -   the call back function owns the buffer and may reference the        buffer and the buffer's payload by the payload address, wherein        the message may be processed later;    -   applications may poll the PCGP system for received messages;        and/or    -   applications may use the call back to set an event and then poll        for received messages.

The communication system may have a limited number of buffers. When PCGPruns out of buffers, drivers may stop receiving new packets and theapplication may be told that the application cannot send new packets. Toavoid this and maintain optimal performance, the application may try toperform one or more procedures, examples of which may include but arenot limited to:

a) The application may keep PCGP up to date with radio status.Specifically, in some embodiments, if the link goes down and PCGP doesnot know, PCGP may accept and queue new messages to send (or not timeoutmessages optimally), which may jam the send queue and delay theapplication from using the link optimally;

b) The application may call “decrement timeouts” regularly. Optimally,in some embodiments, the application may call “decrement timeouts” every20-100 milliseconds unless the processor is asleep. In general, amessage moves fast (milliseconds) slow (seconds) or not at all.Timeouts, in some embodiments, are an attempt to remove “in-flight”messages that should be dropped to free up buffers and bandwidth. Doingthis less often may delay when a new message gets sent, or when theapplication can queue a new message;

c) The application may ask PCGP if it has work to do that is pendingbefore going to sleep. Thus, in some embodiments, if PCGP has nothing todo, driver activity may wake up the system and thus PCGP, and then PCGPwill not need a call to “packetProcessor” or “decrement timeouts” untilnew packets enter the system. In some embodiments, failure to do thismay cause messages that could have been sent/forwarded/receivedsuccessfully to be dropped due to a timeout condition;

d) The application may not hold onto received messages indefinitely: Themessage system relies on prompt replies. If the application is sharingPCGP buffers, then holding onto a message means holding onto a PCGPbuffer. In some embodiments, the receiving node does not know if thesending node has timeout configured for slow or fast radio. This meansthat when a node receives a message it should assume the network's fasttimeout speed; and/or

e) The application may call the “packetProcessor” often. In someembodiments, the call may cause new messages queued by the applicationto get sent and may handle receipt of new messages. The call may alsocause buffers to re-allocate and calling it infrequently may delaymessage traffic.

As shown in FIG. 8I, in some embodiments, at some point the RX drivermay be asked to receive a message from the other side of the interface.To ensure a message does not get dropped, in some embodiments, the RXdriver may ask the buffer manager if there is an available buffer forstoring a new message. The driver may then ask for a buffer pointer andmay start filling the buffer with received data. When a complete messageis received, the RX driver may call a function to route the packet. Theroute function may examine the destination byte in the packet header andmay, in some embodiments, perform one or more of the following: changethe owner to either the other driver, and/or the application, and/or maydetect that the packet is bad and may drop the packet by freeing thebuffer.

PCGP RX overhead may include asking for the next available buffer andcalling the route function. A non-limiting example of code that performssuch a function is as follows:

@ Receive request uint8 i=0, *p; if (Bridge::canReceiveFlowControl( ) ){ p = Bridge::nextBufferRX( ); while (not done) { p[i] = the next byte;} Bridge::route(p); }

A driver may perform a TX by asking the buffer manager for the pointerto the next buffer to send. The TX driver may then ask the other side ofthe interface if it can accept a packet. If the other side denies thepacket, the TX driver may do nothing to the buffer, as its status hasnot changed. Otherwise, the driver may send the packet and mayrecycle/free the buffer. A non-limiting example of code that performssuch a function is as follows:

uint8 *p = Bridge::nextBufferTX( ); if (p != (uint8 *)0) { send thebuffer p; Bridge::recycle(p); }

To avoid forwarding packets that are past the maximum message systemtimeout time, in some embodiments, asking for the nextBuffer may callthe BufferManager:first(uint8 owner) function that may scan for buffersto free. Accordingly, full TX buffers where a timeout is unlikely, maybe freed on the thread that owns the buffer. In some embodiments, abridge that is doing TX (i.e., while looking for the next TX buffer) mayfree all of the TX buffers that are expired before receiving the next TXbuffer for processing.

As shown in FIG. 8J-8L, in some embodiments, during the bufferallocation process, buffers marked free may be transferred to thedrivers to receive new packets, or to PCGP to receive new payloads forTX. Allocation from “free” may be done by the “packetProcessor”function. The number of sends and receives between “packetProcessor”calls may dictate how many LT_Driver_RX, GT_Driver_RX and PCGP_Freebuffers need to be allocated. LT_Driver may represent drivers thathandle addresses that are less than the node address. GT_Driver mayrepresent drivers that handle addresses that are greater than the nodeaddress.

When a driver receives a packet, the driver may put the data into an RXbuffer that gets handed to the router. The router may then reassign thebuffer to PCGP_Receive or to the other driver's TX (not shown). If thebuffer contains obviously invalid data, the buffer may transition tofree.

After a router marks a buffer for TX, the driver may discover the bufferis TX and may send the message. After sending the message, the buffermay immediately become an RX buffer if the driver was low in RX buffers,or the buffer may be freed for re-allocation.

During the “packetProcessor” call, PCGP may process all buffers that therouter marked as PCGP_Receive. At this point, data may be acted upon, sothe CRC and other data items may be checked. If the data is corrupted, astatistic may be incremented and the buffer may be freed. Otherwise, thebuffer may be marked as owned by the application. Buffers marked asowned by the application may be either recycled for the use of PCGP orfreed for reallocation by the buffer manager.

In some embodiments, when the application wants to send a new message,it may be done in a re-entrant friendly/mutual exclusion manner. If thebuffer may be allocated, PCGP may mark the buffer as busy. Once markedbusy, no other thread calling the send or reply functions may grab thisbuffer, as it is owned by this function call's invocation. The remainderof the process of error checking and building the message may be doneoutside the isolated race condition mutual exclusion guarded code. Thebuffer may either transition to free or may become a valid filledCRC-checked buffer and passed to the router. In some embodiments, thesebuffers may not be routed immediately and may be queued so that messagesmay be sent later (assuming that protocol rules allow). Reply messagesmay be marked differently than new send messages because reply messagesmay be routed with a higher priority than regular send messages andreply messages may have no rules limiting how many/when they can besent.

In some embodiments, the PCGP works with flow control, and flow controlmay negotiate the transfer of messages from one node to another node sothat a buffer is never dropped because the other side of an interfacelacks a buffer (which may cause back pressure on the sending node).

Flow control may be part of the shared buffer format. In someembodiments, the first two bytes may be reserved for the driver so thatthe driver never needs to shift the packet bytes. Two bytes may be usedso that one byte is the DMA length−1, and the second byte is to controlthe flow of messages. These same two bytes may be synchronizing bytes ifa PCGP message is transmitted over RS232. Various other configurationsand sizes may be used in various embodiments.

In some embodiments, when a packet is “in-flight”, the packet may be inthe process of being sent by a driver on the way to its destination,being processed by the destination, or being sent back as a response.

Typical delays are as follows:

Interface/Delay cause Delay (seconds) Notes SPI <3 Roughly 400 kbps I2C<1 Waking a CC2510  <6? Clock calibration, min. sleep time. Flow control  <0.2 RF link 20 to 2000 Interference/separation Minutes, never

Accordingly, in some embodiments, messages tend to complete the roundtrip either quickly (e.g., <50 ms); slowly (e.g., one or more seconds);or not at all.

In various embodiments, PCGP may use two different times (set atinitialization) for all timeouts, one for when the RF link is in fastheartbeat mode, and another for when the RF link is in slow mode,however, in other embodiments, the PCGP may use more or less than twodifferent times. In some embodiments, if a message is in-flight and thelink status changes from fast to slow, the timeout may be adjusted andthe difference between fast and slow may be added to the time-to-livecounter for the packet. No additional transitions back and forth mayaffect the time-to-live time for the message.

In some embodiments, there is a second timeout that may be twice as longas the slow timeout that is used to monitor buffer allocation insidePCGP. Accordingly, if a message is “stuck” inside a driver and has notbeen sent due to e.g., flow control or hardware damage, the buffer maybe freed by the buffer manager, resulting in the buffer being dropped.For a “new” message, this may mean that the packet already timed out andthe application was already given a reply saying the message wasn'tdelivered, resulting in the buffer being freed. Since the driver pollsthe buffer manager for buffers that need to be sent, the buffer is freedup so that a message that could be sent is handed to the driver the nexttime that it unblocks. For a reply message, the reply may simply getdropped and the sending node may time out.

In some embodiments, the PCGP messaging system may pass messages thatcontain header information and payload. However, in various embodiments,the PCGP messaging system may pass messages that contain differentinformation. Outside of PCGP, the header may be a set of data items in acall signature. In some embodiments, however, internal to PCGP, theremay be a consistent, driver friendly byte layout. In some embodiments,drivers may insert bytes either into the PCGP packet or before the PCGPpacket such:

-   -   DE, CA: Synch bytes for use with RS232, nominal value of 0xDE,        0xCA or 0x5A, 0xA5.    -   LD: Driver DMA length byte, equals amount driver is pushing in        this DMA transfer, which is the total size, not including the        size byte or synch bytes.    -   Cmd: Driver command and control byte used for flow control.    -   LP: PCGP packet length, always the total header+payload size in        bytes+CRC size. LD=LP+1.    -   Dst: Destination address.    -   Src: Source address    -   Cmd: Command byte    -   Scd: Sub command byte    -   AT: Application Tag is defined by the application and has no        significance to PCGP. It allows the application to attach more        information to a message e.g., the thread from which the message        originated.    -   SeqNum: thirty-two bit sequence number is incremented by PCGP        for a new message sent, guarantees the number will not wrap,        acts as a token, endianess isn't relevant.    -   CRC16: A sixteen bit CRC of the PCGP header and payload.

An example of a message with no payload, cmd=1, subcmd=2 is as follows:

0xDE, 0xCA, 0xC, 0x5, 0x14, 1, 2, 0, 0, 0, 0, 0x1, crchigh, crclow.

0x0D, cmd, 0xC, 0x5, 0x14, 1, 2, 0, 0, 0, 0, 0x1, crchigh, crclow.

There may be several advantages to this methodology, examples of whichmay include but are not limited to:

-   -   In various embodiments, most of the hardware DMA engines may use        the first byte to define how many additional bytes to move, so        in this methodology, drivers and PCGP may share buffers.    -   A byte may be provided right after the DMA length to pass flow        control information between drivers.    -   Driver length and “Cmd” byte may be outside the CRC region so        they may be altered by the driver, may be owned by the driver        transport mechanism, and the driver may guard for invalid        lengths.    -   There may be a separate PGCP packet length byte that is CRC        protected. Accordingly, the application may trust that payload        length is correct.    -   The endianness of the sequence number may not be relevant, as it        is just a byte pattern that may be matched that happens to also        be a thirty-two bit integer.    -   The sequence number may be four bytes aligned to the edge of the        shared buffer pool length.    -   There may be optional RS232 synchronizing bytes so that users        may move cables around while debugging a message stream and both        sides of the interface may resynchronize.    -   The application, driver and PCGP may share buffers and may        release them by pointer.

Although, in some embodiments, PCGP may not be an event driven softwaredesign, but it may be used in event driven architectures by how thesub-classes are written. Data may be exchanged between the classesconceptually (as shown in FIG. 8M-8N).

In some embodiments, some event model in the driver may wake the driver,may receive a message and may pass the message through the bridge intothe buffer manager that routes the message to new owner of the newmessage (through a bridge to either a driver or PCGP).

The following summarizes some exemplary events:

Event: Possible use: Where this occurs: When a new send or reply Decideto run Inside is queued, or decTimeouts packetProcessor.PCGP::sendInternal generates a timeout reply. When a messages is Decideto run BufferManager::give received for PCGP. packetProcessor. When adriver has Wake driver for TX. BufferManager::give something new tosend. When a Driver RX buffer Turn off flow BufferManager::give becomesavailable. control.

The following illustrative example shows how the PCGP event model maywork with Nucleus to wakeup the PCGP task after every message send,reply, or decTimeout that generated a NACK:

class PcgpOS : public Pcgp {  virtual void schedulePacketProcessor(void) { OS_EventGrp_Set(g_RCVEvGrps[EVG_RF_TASK].pEvgHandle,  RfRadioTxEvent,OS_EV_OR_NO_CLEAR);  } }

The following is a pseudo code driver that is event based, illustratinghow driver events work. The Driver subclasses Bridge and overrideshasMessagesToSend and flowControlTurnedOff to schedule the TX and RXfunctions to run if they are not already running.

class SPI_Driver : public Bridge { virtual void hasMessagesToSend( ) {Trigger_ISR(TX_ISR, this); } virtual void flowControlTurnedOff( ) {Trigger_ISR(RX_ISR, this); } static void TX_RetryTimer( ) {Trigger_ISR(TX_ISR, this); } static void TX_ISR(Bridge *b) {DisableISRs( ); do { uint8 *p = b−>nextBufferTX( ); if (p == null)break; if (b−>_bufferManager−>bufferTimedOut(p)==false) { if(OtherSideSPI_FlowControl( ) == false) { Trigger TX_RetryTimer in 20msec. break; } send(p); } free(p); } while (true) ; EnableISRs( ); }static void RX_ISR(Bridge *b) { DisableISRs( ); do { uint8* p =b−>nextBufferRX( ); if (p == null) break; uint i; while (not donereceiving) p[i++] = getChar( ); b−>route (p); } while (true) ;EnableISRs( ); } }

One or more, but not limited to, the following statistics may besupported by PCGP:

-   -   Number of packets sent;    -   Number of packets received;    -   CRC errors;    -   Timeouts; and    -   Buffer unavailable (ran out of buffers)

In various embodiments, PCGP may be designed to run in multipleprocessing environments. Most parameters may be run time configuredbecause it facilitates testing, and any run time fine tuning forperformance. Other parameters may be compile time e.g., anything thatalters memory allocation must be done statically at compile time andstill other parameters may be used in various embodiments.

The following may be compile time configuration #defines that may varywhere PCGP is implemented:

-   -   # driver bytes: may be two bytes reserved in the common buffer        scheme for the driver, but, in some embodiments, this may be a        compile time option to accommodate other drivers such as RF        protocol.    -   # RX driver buffers: may be tuned to how many buffers desired        for that processor/traffic flow, etc.    -   # PCGP RX buffers: may be tuned to how many buffers desired for        that processor/traffic flow, etc.    -   Total # of buffers: may be tuned to how many buffers desired for        that processor.

In some embodiments, the CRC may be used to ensure data integrity. Insome embodiments, if a CRC is invalid, it may not be delivered to theapplication and the CRC error may be tracked. The message may eventuallytimeout and may be retried by the originator.

Likewise, if the messaging system informs the application that a messagewas delivered when it was not, this may not be desirable for the system.The Stop Bolus Command is an example of such a command. This may bemitigated by the Request/Action sequence of messages which may berequired by the application to change therapy. In some embodiments, theremote interface 802 may receive a matching command from the device 800application to consider the message delivered.

In some embodiments, a reference way of interfacing PCGP into theNucleus OS system on the ARM 9 (as shown in FIG. 8O) may be used.

As shown in FIG. 8P, the pcgpOS.cpp file may instantiate a PCGP nodeinstance (Pcgp, a Bridge, etc.) and may provide through pcgpOS.h a ‘C’linkable set of function calls that provide a ‘C’ language interface tothe C++ code. This may simplify the ‘C’ code as the objects acted uponare implicit.

The following general rules may be applied in some embodiments:

-   -   PCGP may run on all nodes: any driver may support a generic        driver interface.    -   Race conditions may not be permitted.    -   May support half duplex on the SPI port between slave processor        and master processor.    -   Data transfer may not be attempted; as it either succeeds or        returns fail/false.    -   May require low overhead (time, processing, bandwidth wasted).    -   May support CC2510 operating at DMA (fast) SPI clock rates.

In some embodiments, SPI flow control may prevent data from being sentif the receiving side does not currently have an empty buffer to placethe packet. In some embodiments, this may be accomplished by asking forpermission to send and waiting for a response indicating that you havebeen cleared to do so. In some embodiments, another method may be usedto indicate to the other side that there are currently no free buffersand the transfer should be attempted at a later time.

In some embodiments, all transmission may begin with a length byte thatindicates the number of bytes to be sent, not including the length byteitself. Following, the length may be a single byte indicating thecommand being sent.

In some embodiments, the actual transmission of a packet may be thelength of the packet plus one for the command byte, followed by thecommand byte for a message appended and finally the packet itself.However, in other embodiments, the transmission of the packet may vary.

In addition to the command bytes that will be sent, an additionalhardware line called the FlowControl line may be added to thetraditional four SPI signals. This line may be used to allow theprotocol to run as quickly as possible without a need for preset delays.It also allows the slave processor to tell the master processor that ithas a packet waiting to be sent, thus eliminating the need for themaster processor to poll the slave processor for status.

The following exemplary command values may be used in some embodiments:

Commands to be Sent by the Master Processor:

Command Value Description M_RTS 0xC1 Master is requesting to send apacket M_MSG_APPENDED 0xC2 Master is sending a packet M_CTS 0xC3 Masteris tell slave it is Cleared to Send M_ERROR 0xC4 An Error condition hasbeen encounteredCommands to be Sent by the Slave Processor:

Command Value Description S_PREPARING_FOR_RX 0xA1 Slave is prepare thedma to receive a packet S_RX_BUFF_FULL 0xA2 Slave is currently out of RXbuffers, retry later S_MSG_APPENDED 0xA3 Slave is sending a packetS_ERROR 0xA4 An Error condition has been encountered

As illustrated in FIG. 8Q, when the slave processor has a packet to sendto the master processor, the slave processor may notify the masterprocessor (for example, by asserting the FlowControl line) that it has apending packet that is waiting to be sent. Doing so may result in an IRQon the master processor at which time the master processor may decidewhen to go retrieve the message from the slave processor. Retrieving thepacket may be delayed at the discretion of the master processor, and themaster processor may even decide to attempt to send a packet to theslave processor before retrieving from the slave processor.

In some embodiments, the master processor may begin the retrieval bysending the slave processor M_CTS commands; in some embodiments, thismay be repeated until the slave processor responds by sending theS_MSG_APPENDED command along with the packet itself. The FlowControlline may be cleared after the packet has been sent. If a M_CTS commandis received by the slave processor when one is not expected, the M_CTScommand may be ignored.

As illustrated in FIG. 8R, in some embodiments, when the masterprocessor has a packet to send to the slave processor, the masterprocessor may initiate the transfer by sending a M_RTS command. Uponreceiving the M_RTS command, if the slave processor currently has a sendpacket pending, in some embodiments, the slave processor will lower theFlowControl line so that it may be re-used as a Cleared To Send signal.The slave processor may then tell the master processor that it is in theprocess of preparing the SPI DMA to receive the packet, during whichtime the master processor may stop clocking bytes onto the bus and mayallow the slave processor to finish preparing for the receive.

In some embodiments, the slave processor may then indicate it is readyto receive the full packet by raising the FlowControl line (which is nowused as the CTS signal). Upon receiving the CTS signal, the masterprocessor may proceed to send the M_MSG_APPENDED command along with thepacket itself.

After the completion of the transfer, the slave processor may lower theFlowControl line. If a packet was pending at the start of the transfer,or a send occurred on the slave processor when the packet was beingreceived, the slave processor may reassert the FlowControl line nowindicating that it has a pending packet.

Referring again to FIG. 8 , device 800 may include switch assembly 810coupled to electrical control assembly 510 (FIG. 5D) that may allow auser (not shown) to perform at least one, and in some embodiments, aplurality of tasks. One illustrative example of such a task, inembodiments where the device 800 is an infusion pump or other drugdelivery device, is the administration of a bolus dose of the infusiblefluid (e.g., insulin) without the use of a display assembly. The remoteinterface 802 may allow the user to enable/disable/configure the device800 to administer the bolus dose of insulin.

The display assembly 804 may be configured, at least in part, to enablethe user to manipulate menu-based information rendered the on displayassembly 804. An example may be that display assembly 804 is a touchscreen. In some embodiments, the touch screen/display assembly 804 maybe configured so that the rate at which e.g. the highlighted portion ofa menu scrolls “upward” or “downward” varies depending upon thedisplacement of the finger of the user with respect to a point oforigin. Therefore, in some embodiments, for example, if the user wishesto quickly scroll “upward”, the user may position their finger near thetop of display assembly 804. Likewise, if the user wishes to quicklyscroll “downward”, the user may position their finger near the bottom ofthe display assembly 804. Additionally, if the user wishes to slowlyscroll “upward”, the user may position their finger slightly “upward”with respect to a point of origin. Further, if the user wishes to slowlyscroll “downward”, the user may position their finger slightly“downward” with respect to a point of origin. Once the appropriate menuitem is highlighted, the user may select the highlighted menu itemeither by touching the screen a predetermined number of times in eitherthe vicinity of the highlighted menu item, for example, and/or by usingthe one or more switch assemblies 806 that may be included on the remoteinterface 802 in some embodiments.

As discussed above, in one embodiment of the above-described infusionpump device, the device 800 may be used to communicate with the remoteinterface 802. When such a remote interface 802 is utilized, the device800 and the remote interface 802 may routinely contact each other toensure that the two devices are still in communication with each other.For example, the device 800 may “ping” the remote interface 802 toensure that the remote interface 802 is present and active. Further, theremote interface 802 may “ping” the device 800 to ensure that the device800 is still present and active. In the event that one of the device 800and the remote interface 802 fails to establish communication with oneother, the one (i.e., either the device 800 or the remote interface 802)that is unable to establish communication may sound a “separation”alarm. For example, assume that the remote interface 802 is left in thecar of the user, while the device 800 is in the pocket of the user.Accordingly and after a defined period of time, the device 800 may beginsounding the “separation” alarm, indicating that communication with theremote interface 802 cannot be established. In some embodiments, theuser may acknowledge and or silence the “separation” alarm by usingswitch assembly 810.

In various embodiments, the user may define and administer a delivery offluid using the switch assembly 810 of the device 800 while the remoteinterface 802 is not in communication the device 800, the device 800 maystore information concerning the administered bolus insulin dose withina log file (not shown) stored within the device 800. This log file (notshown) may be stored within nonvolatile memory (not shown) includedwithin the device 800. Upon communication being reestablished betweenthe device 800 and the remote interface 802, the device 800 may providethe information concerning the administered bolus insulin dose storedwithin the log file (not shown) of the device 800 to the remoteinterface 802.

Further, in some embodiments, where the user anticipates separating theremote interface 802 from the device 800, the user may configure thedevice 800 and the remote interface 802 to be in “separation” mode, thuseliminating the occurrence of the above-described “separation” alarms.However, in some embodiments, the remote interface 802 and the devicee800 may continue to “ping” each other so that when they come back intocommunication with each other, the device 800 and the remote interface802 may automatically exit “separation” mode.

Further, in some embodiments, if the user anticipates traveling in anairplane, the user, using the remote interface 802 may configure thedevice 800 and the remote interface 802 to be in “airplane” mode, inwhich each of the device 800 and the remote interface 802 suspend anyand all data transmissions. While in “airplane” mode, the device 800 andthe remote interface 802 may, or may not, continue to receive data.

In some embodiments, the switch assembly 810 may be used to performadditional functions, which may include, but are not limited to, one ormore of the following: checking the battery life of the reusable portion502; pairing reusable portion 502 with the remote interface 802; and/oraborting the administration of a bolus does of infusible fluid.

Referring also to FIG. 9A and as discussed above, in some embodiments,to, for example, enhance the safety of the device 800, electricalcontrol assembly 516 may include two separate and distinctmicroprocessors, namely supervisor processor 900 and command processor902. Specifically, command processor 902 may perform the functions suchas, but not limited to, generating pump drive signals and may controlrelay/switch assemblies that control the functionality of, for example,shape memory actuators. The command processor 902 may receive feedbackfrom a signal conditioner 908 concerning the condition (e.g., voltagelevel) of the voltage signal applied to pump actuators 922, 924, whichin some embodiments, may be shape memory actuators. The commandprocessor 900 may control relay/switch assembly 910 independently ofrelay/switch assemblies 904, 906. Accordingly, when, for example, aninfusion event is desired, both of supervisor processor 900 and commandprocessor 902 must agree that the infusion event is proper (which mayinclude whether the infusion event does not exceed any set limitationsof the system, when inherent or user selected/pre programmed, and/or isintentional) and must both actuate their respective relays/switches. Inthe event that either of the supervisor processor 900 and the commandprocessor 902 fail to actuate their respective relays/switches, theinfusion event will not occur. Accordingly through the use of thesupervisor processor 900 and command processor 902 and the cooperationand concurrence that must occur, the safety of the device 800 isenhanced.

In some embodiments, the supervisor processor 900 may prevent thecommand processor 902 from delivering when it is not proper and/or mayalarm if the command processor 902 does not deliver when it should bedelivering. The supervisor processor 900 may deactivate the relay/switchassembly, for example, if the command processor 902 actuates the wrongswitch, or if the command processor tries to apply power for too long.

The supervisor processor 900 may redundantly perform calculations forhow much fluid should be delivered (i.e., double checking thecalculations of the command processor 902). In some embodiments, thecommand processor 902 may determine the delivery schedule, and thesupervisor processor 900 may redundantly check/confirm thosecalculations.

The supervisor processor 900 may redundantly hold the profiles (forexample, delivery profiles and/or user preferences that arepreprogrammed/pre-entered into the device) in RAM, so that the commandprocessor 902 may be doing the correct calculations, but if it has badRAM, would cause the command to come up with the wrong result. Thus, thesupervisor processor 900 uses its local copy of the profile/userpreference, e.g., a basal profile, etc., to double check/confirm.

The supervisor processor 900 may double check one or more calculationsperformed by the device, for example, AVS measurements, by reviewing theAVS calculations and applied safety checks. In some embodiments of thedevice, for example, each time AVS measurement is taken, the supervisorprocessor 900 double checks.

Referring also to FIG. 9B, one or more of supervisor processor 900 andcommand processor 902 may perform diagnostics on various portions of theinfusion pump/device 800. For example, voltage dividers 912, 914 may beconfigured to monitor the voltages (V1 & V2 respectively) sensed atdistal ends of e.g., shape memory actuator 922. The value of voltages V1& V2 in combination with the knowledge of the signals applied torelay/switch assemblies 904, 910 may allow for diagnostics to beperformed on various components of the circuit shown in FIG. 9B (in amanner similar to that shown in illustrative diagnostic table 916).

As discussed above and as illustrated in FIGS. 9A-9B, to enhance thesafety of the device 800, electrical control assembly 910 may include aplurality of microprocessors (e.g., supervisor processor 900 and commandprocessor 902), each of which may be required to interact and concur inorder to effectuate action, for example, where the device 800effectuates the delivery of a drug, the action may be the delivery of adose of the e.g., infusible fluid. In the event that the microprocessors900, 902 fail to interact/concur, the delivery of the dose of infusiblefluid/action may fail and one or more alarms may be triggered, thusenhancing the safety and reliability of the device 800.

A master alarm may be utilized that tracks the error, for example,volume error, which may refer to the volume of fluid delivered beingless than or more than requested, over time. Accordingly, if the sum ofthe errors becomes too large, the master alarm may be initiated,indicating that something may be wrong with the system. Accordingly, themaster alarm may be indicative of a total volume comparison beingperformed and a discrepancy being noticed. A typical value of thediscrepancy required to initiate the master alarm in embodimentsincluding the infusion pump described above may be 1.00 milliliters. Themaster alarm may monitor the sum in a leaky fashion (i.e., inaccuracieshave a time horizon).

Referring also to FIGS. 10A-10B, there is shown one such illustrativeexample of such interaction amongst multiple microprocessors, in thisexample, the interaction is during the delivery of a dose of theinfusible fluid by the infusion pump. Specifically, the commandprocessor 902 may first determine 900 the initial volume of infusiblefluid within a volume sensor chamber. The command processor 902 may thenprovide 1002 a “pump power request” message to the supervisor processor900. Upon receiving 1004 the “pump power request” message, thesupervisor processor 900 may e.g., energize 1006 relay/switch 910 (thusenergizing the shape memory actuator 922) and may send 1008 a “pumppower on” message to the command processor 902. Upon receiving 1010 the“pump power on” message, the command processor 902 may actuate 1012e.g., the pump assembly (by energizing relay/switch 904 and whichenergizes the valve assembly 514), during which time the supervisorprocessor 900 may monitor 1014 the actuation of e.g., the pump assembly.

Once actuation of the pump assembly is complete, the command processor902 may provide 1014 a “pump power off” message to the supervisorprocessor 900. Upon receiving 1016 the “pump power off” message, thesupervisor processor 900 may de-energize 1018 relay/switch 910 andprovide 1020 a “pump power off” message to the command processor 902.Upon receiving 1022 the “pump power off” message, the command processor902 may measure 1024 the quantity of infusible fluid pumped by the pumpassembly (which may, in some embodiments, include the valve assembly514). This may be accomplished by measuring the current quantity offluid within a volume sensor chamber and comparing it with the quantitydetermined above (in step 1000). Once determined 1024, the commandprocessor 902 may provide 1026 a “valve open power request” message tothe supervisor processor 900. Upon receiving 1028 the “valve open powerrequest” message, the supervisor processor 900 may energize 1030relay/switch 910 (thus energizing shape memory actuator 924) and maysend 1032 a “valve open power on” message to the command processor 902.Upon receiving 1034 the “valve open power on” message, the commandprocessor 902 may actuate 1036 e.g., measurement valve assembly (byenergizing relay/switch 906), during which time the supervisor processor900 may monitor 1038 the actuation of e.g., a measurement valveassembly.

Once actuation of a measurement valve assembly is complete, the commandprocessor 902 may provide 1040 a “valve power off” message to thesupervisor processor 900. Upon receiving 1042 the “valve power off”message, the supervisor processor 900 may de-energize 1044 relay/switch910 and provide 1046 a “valve power off” message to the commandprocessor 902.

Upon receiving 1048 the “valve power off” message, the command processor902 may provide 1050 a “valve close power request” message to thesupervisor processor 900. Upon receiving 1052 the “valve close powerrequest” message, the supervisor processor 900 may energize 1054relay/switch 910 (thus energizing a shape memory actuator) and may send1056 a “power on” message to command processor 902. Upon receiving 1058the “power on” message, the command processor 902 may actuate 1060 anenergizing relay/switch (not shown) that is configured to energize theshape memory actuator, during which time the supervisor processor 900may monitor 1062 the actuation of e.g., the shape memory actuator.

In various embodiments, the shape memory actuator may be anchored on afirst end using an electrical contact. The other end of the shape memoryactuator may be connected to bracket assembly. When the shape memoryactuator is activated, the shape memory actuator may pull the bracketassembly forward and release the valve assembly. As such, themeasurement valve assembly may be activated by way of the shape memoryactuator. Once the measurement valve assembly has been activated, thebracket assembly may automatically latch the measurement valve assemblyinto the activated position. Actuating the shape memory actuator maypull the bracket assembly forward and release the measurement valveassembly. Assuming the shape memory actuator is no longer activated, themeasurement valve assembly may move to a de-activated state once thebracket assembly has released the measurement valve assembly.Accordingly, by actuating the shape memory actuator, the measurementvalve assembly may be deactivated.

Once actuation of the shape memory actuator is complete, the commandprocessor 902 may provide 1064 a “power off” message to supervisorprocessor 900. Upon receiving 1066 the “power off” message, thesupervisor processor 900 may de-energize 1068 relay/switch 910 and mayprovide 1070 a “power off” message to the command processor 902. Uponreceiving 1072 the “power off” message, the command processor 902 maydetermine the quantity of infusible fluid within the volume sensorchamber, thus allowing command processor 902 to compare this measuredquantity to the quantity determined above (in step 1024) to determine1074 the quantity of infusible fluid delivered to the user.

In the event that the quantity of infusible fluid delivered 1074 to theuser is less than the quantity of infusible fluid specified for thebasal/bolus infusion event, the above-described procedure may berepeated (by way of loop 1076).

Referring also to FIG. 11 , there is shown another illustrative exampleof the interaction amongst processors 900, 902, this time during thescheduling of a dose of infusible fluid. The command processor 902 maymonitor 1100, 1102 for the receipt of a basal scheduling message or abolus request message (respectively). Upon receipt 1100, 1102 of eitherof these messages, the command processor 902 may set 1104 the desireddelivery volume and may provide 1106 a “delivery request” message to thesupervisor processor 900. Upon receiving 1108 the “delivery request”message, supervisor processor 900 may verify 1110 the volume defined1104 by command processor 902. Once verified 1110, the supervisorprocessor 900 may provide 1112 a “delivery accepted” message to thecommand processor 902. Upon receipt 1114 of the “delivery accepted”message, the command processor 902 may update 1116 the remote interface(e.g., the remote interface discussed above and illustrated in FIGS. 6-8) and execute 1118 delivery of the basal/bolus dose of infusible fluid.The command processor 902 may monitor and update 1122 the total quantityof infusible fluid delivered to the user (as discussed above andillustrated in FIGS. 10A-10B). Once the appropriate quantity ofinfusible fluid is delivered to the user, the command processor 902 mayprovide 1124 a “delivery done” message to the supervisor processor 900.Upon receipt 1126 of the “delivery done” message, the supervisorprocessor 900 may update 1128 the total quantity of infusible fluiddelivered to the user. In the event that the total quantity of infusiblefluid delivered 1118 to the user is less than the quantity defined above(in step 1104), the infusion process discussed above may be repeated (byway of loop 1130).

Referring also to FIG. 12 , there is shown an example of the manner inwhich the supervisor processor 900 and the command processor 902 mayinteract while effectuating a volume measurements by way of the volumesensor assembly (as described above).

Specifically, the command processor 902 may initialize 1250 volumesensor assembly and begin collecting 1252 data from the volume sensorassembly, the process of which may be repeated for each frequencyutilized in the sine sweep, for example, as described in U.S.Publication No. US-2009-0299277-A1 published Dec. 3, 2009. Each timethat data is collected for a particular sweep frequency, a data pointmessage may be provided 1254 from the command processor 902, which maybe received 1256 by the supervisor processor 900.

Once data collection 1252 is completed for the entire sine sweep, thecommand processor 902 may estimate 1258 the volume of infusible fluiddelivered by infusion the device 800. The command processor 902 mayprovide 1260 a volume estimate message to the supervisor processor 900.Upon receiving 1262 this volume estimate message, the supervisorprocessor 900 may check (i.e., confirm) 1264 the volume estimatemessage. Once checked (i.e., confirmed), the supervisor processor 900may provide 1266 a verification message to the command processor 902.Once received 1268 from the supervisor processor 900, the commandprocessor 902 may set the measurement status for the dose of infusiblefluid delivered by the volume sensor assembly.

As discussed above (and referring temporarily to FIGS. 1A-5I), thevarious embodiments and components of the infusion pump system may beconfigured using a the remote interface 802 (see FIGS. 6-8 ). Whenconfigurable by way of the remote interface 802, the infusion pump 800may include telemetry circuitry (not shown) that allows forcommunication (e.g., wired or wireless) between the infusion pump ande.g., the remote interface 802, thus allowing the remote interface 802to remotely communicate with the infusion pump 800. Various embodimentsof the remote interface 802 (which may also include telemetry circuitry(not shown) and may be capable of communicating with the infusion pump800) may include a display assembly (602, 702, 804) and at least oneinput assembly 608, 604, 610, 606, 704, 702, 804 806), however, invarious embodiments, the display assembly may also serve as an inputassembly.

When used herein, the term remote interface refers to any embodiment ofthe remote interface. However, although the embodiment shown in FIG. 8is used for illustrative purposes below, the description is not limitedto that embodiment of the remote interface shown in FIG. 8 .

In some embodiments, the remote interface 802 may include twoprocessors, one processor (e.g., which may include, but is not limitedto a CC2510 microremote interface/RF transceiver, available from ChipconAS, of Oslo, Norway) may be dedicated to radio communication, e.g., forcommunicating with the device 800. The second processor included withinthe remote interface 802 (which may include but are not limited to anARM920T and an ARM922T manufactured by ARM Holdings PLC of the UnitedKingdom) may be a command processor and may perform data processingtasks associated with e.g., configuring the device 800. However, invarious other embodiments, as described below, the remote interface 802may include various processors and/or communications protocols and/orvarious antennas for communication.

Further and as discussed above, one embodiment of electrical controlassembly 516 may include three microprocessors. One processor (e.g.,which may include, but is not limited to a CC2510 microremoteinterface/RF transceiver, available from Chipcon AS, of Oslo, Norway)may be dedicated to radio communication, e.g., for communicating withthe remote interface 802. Two additional microprocessors (e.g.,supervisor processor 1800 and command processor 1802) may effectuate thedelivery of the infusible fluid (as discussed above). Examples ofsupervisor processor 1800 and command processor 1802 may include, but isnot limited to an MSP430 microremote interface, available from TexasInstruments Inc. of Dallas, Tex.

The OS may be a non-preemptive scheduling system, in that all tasks mayrun to completion before the next task is allowed to run regardless ofpriority. Additionally, context switches may not be performed. When atask completes executing, the highest priority task that is currentlyscheduled to run may then be executed. If no tasks are scheduled toexecute, the OS may place the processor (e.g., the supervisor processor900 and/or the command processor 902) into a low power sleep mode andmay wake when the next task is scheduled. The OS may only be used tomanage main loop code and may leave interrupt-based functionalityunaffected.

In some embodiments, the OS may be written to take advantage of the C++language. Inheritance as well as virtual functions may be key elementsof the design, allowing for easy creation, scheduling and managing oftasks.

At the base of the OS infrastructure may be the ability to keep track ofsystem time and controlling the ability to place the processor in LowPower Mode (LPM; also known as sleep mode). This functionality alongwith the control and configuration of all system clocks may beencapsulated by the SysClocks class.

The SysClocks class may contain the functionality to place the processor(e.g., the supervisor processor 900 and/or the command processor 902)into LPM to reduce energy consumption. While in LPM, the slow real timeclock may continue to run while the fast system clock that runs the CPUcore and most peripherals may be disabled.

In some embodiments, placing the processor into LPM may always be doneby the provided SysClocks function. This function may contain allrequired power down and power up sequences resulting in consistencywhenever entering or exiting LPM. Waking from LPM may be initiated byany interrupts based on the slow clock.

The OS may keep track of three aspects of time: seconds, millisecondsand the time of day. Concerning seconds, SysClocks may count secondsstarting when the processor comes out of reset. The second counter maybe based on the slow system clocks and, therefore, may incrementregardless of whether the processor is in LPM or at full power. As aresult, it is the boundary at which the processor may wake from sleep toexecute previously scheduled tasks. If a task is scheduled to runimmediately from an interrupt service routine (ISR), the ISR may wakethe processor from LPM on exit and the task may be executed immediately.Concerning milliseconds, in addition to counting the seconds since poweron, SysClocks may also count milliseconds while the processor is in fullpower mode. Since the fast clock is stopped during LPM, the millisecondcounter may not increment. Accordingly, whenever a task is scheduled toexecute based on milliseconds, the processor may not enter LPM.Concerning time of day, the time of day may be represented withinSysClocks as seconds since a particular point time (e.g., seconds since1 Jan. 2008 and/or in some embodiments, POSIX standard time, 1 Jan.1971).

The SysClocks class may provide useful functionality to be usedthroughout the Command and Supervisor project code base. The code delaysmay be necessary to allow hardware to settle or actions to be completed.SysClocks may provide two forms of delays, a delay based on seconds or adelay based on milliseconds. When a delay is used, the processor maysimply wait until the desired time has passed before continue with itscurrent code path. Only ISRs may be executed during this time. SysClocksmay provide all of the required functionality to set or retrieve thecurrent time of day.

The word “task” may be associated with more complex scheduling systems;therefore within the OS, task may be represented by and referred to asManaged Functions. The ManagedFunc class may be an abstract base classthat provides all the necessary control members and functionality tomanage and schedule the desired functionality.

The ManagedFunc base class may have five control members, two schedulingmanipulation member functions, and one pure virtual execute functionthat may contain the managed functionality. All of the ManagedFunccontrol members may be hidden from the derived class and may only bedirectly set by the derived class during creation, thus simplifying theuse and enhancing the safety of the infusion pump 800.

In some embodiments, the Function ID may be set at the time of creationand may never be changed. All Function IDs may be defined within asingle .h file, and the base ManagedFunc constructor may stronglyenforce that the same ID may not be used for more than one managedfunction. The ID may also define the priority of a function (withrespect to other functions) based upon the function ID assigned, whereinhigher priority functions are assigned lower function IDs. The highestpriority task that is currently scheduled to execute may execute beforelower priority tasks.

All other control members may be used to represent the function'scurrent scheduled state, when it should be executed, and if (uponexecution) the function should be rescheduled to execute in a previouslyset amount of time. Manipulation of these controls and states may beallowed but only through the public member functions (thus enforcingsafety controls on all settings).

To control the scheduling of a managed function, the set start and setrepeat functions may be used. Each of these member functions may be asimple interface allowing the ability to configure or disable repeatsettings as well as control whether a managed function is inactive,scheduled by seconds, milliseconds, or time of day.

Through inheritance, creating a Managed Function may be done by creatinga derived class and defining the pure virtual ‘execute’ functioncontaining the code that needs to be under scheduling control. TheManagedFunc base class constructor may be based upon the unique ID of afunction, but may also be used to set default control values to be usedat start up.

For example to create a function that runs e.g., thirty seconds afterstart up and every e.g., 15 seconds thereafter, the desired code isplaced into the virtual execute function and the function ID, scheduledby second state, thirty second start time, and repeat setting of fifteenseconds is provided to the constructor.

The following is an illustrative code example concerning the creation ofa managed function. In this particular example, a “heartbeat” functionis created that is scheduled to execute for the first time one secondafter startup of the device 800 and execute every ten secondsthereafter:

#include “ManagedFunc.h” // The SendGoodFunc is a “heartbeat” statusmessage class SendGoodFunc : public ManagedFunc { public: // Initializethe managed func to run 2 seconds after start up // and repeat everysecond. SendGoodFunc( ) : ManagedFunc(IPC_SEND_GOOD, SCHEDULED_SEC, 1,true, 10) { }; ~SendGoodFunc( ) { }; protected: void execute(void); };void SendGoodFunc::execute(void) { // << code to send the heartbeat >> }SendGoodFunc g_sendGoodFunc; // to manipulate the heartbeat timingsimply call: // g_sendGoodFunc.setFuncStart(...) org_sendGoodFunc.setRepeat( ... )

The actual execution of the Managed Functions may be controlled andperformed by the SleepManager class. The SleepManager may contain theactual prioritized list of managed functions. This prioritized list offunctions may automatically be populated by the managed functioncreation process and may ensure that each function is created properlyand has a unique ID.

The main role of the SleepManager class may be to have its ‘manage’function called repeatedly from the processors main loop and/or from aendless while loop. Upon each call of manage, the SleepManager mayexecute all functions that are scheduled to run until the SleepManagerhas exhausted all scheduled functions; at which time the SleepManagermay place the processor in LPM. Once the processor wakes from LPM, themanage function may be reentered until the processor is again ready toenter LPM (this process may be repeated until stopped, e.g., by a useror by the system).

If the processor has to be kept in full power mode for an extendedperiod of time (e.g., while an analog-to-digital conversion is beingsampled), the SleepManager may provide functionality to disable enteringLPM. While LPM is disabled, the manage function may continuously searchfor a scheduled task.

The SleepManager may also provide an interface to manipulate thescheduling and repeat settings of any managed function through the useof the unique ID of the function, which may allow any section of code toperform any required scheduling without having direct access to orunnecessary knowledge of the desired ManagedFunc object.

Radio circuitry included within the device 800 and the remote interface802 may effectuate wireless communication between the remote interface802 and device 800. In some embodiments, a 2.4 GHz radio communicationschip (e.g., a Texas Instruments CC2510 radio transceiver) with aninternal 8051 microremote interface may be used for radiocommunications.

The radio link may balance the following three objectives: linkavailability; latency; and energy.

Concerning link availability, the remote interface 802 may provide theprimary means for commanding the device 800 and may provide detailedfeedback to the user by way of the graphical user interface (GUI)(display assembly 804) of the remote interface 802. Concerning latency,the communications system may be designed to provide for low latency todeliver data from the remote interface 802 to the device 800 (and viceversa). Concerning energy, both the remote interface 802 and the device800 may have a maximum energy expenditure for radio communications.

The radio link may support half-duplex communications. In someembodiments, the remote interface 802 may be the master of the radiolink, initiating all communications. In these embodiments, the device800 may only respond to communications and may not initiatecommunications. The use of such a radio communication system may providevarious benefits, such as: increased security: a simplified design(e.g., for airplane use); and coordinated control of the radio link. Inother embodiments, the device 800 may instigate an action, butcommunication may be instigated by the remote interface 802.

Referring also to FIG. 12 , there is shown one illustrative example ofthe various software layers of the radio communication system discussedabove.

In some embodiments, the radio processors included within the remoteinterface 802 and the device 800 may transfer messaging packets betweenan SPI port and a 2.4 GHz radio link (and vice versa). In someembodiments, the radio may always be the SPI slave. On the device 800,the radio processor (PRP) 918 (See FIGS. 9A-9B) may, in someembodiments, service two additional nodes (the number of additionalnodes may vary in various embodiments) over the SPI port that areupstream (namely the command processor 900 and the supervisor processor902). In some embodiments, on the remote interface 802, the radioprocessor 918 (CRP) may service at least one additional node over theSPI port that may be either upstream or downstream, for example, in someembodiments, the above-described remote control processor (UI) and aContinuous Glucose Monitor (CGM) and/or a Blood Glucose Monitor (BGM)

A messaging system may allow for communication of messages betweenvarious nodes in the network. The UI processor of the remote interface802 and e.g., the supervisor processor 900 may use the messaging systemto configure and initiate some of the mode switching on the two systemradios. It may be also used by the radios to convey radio and linkstatus information to other nodes in the network.

In some embodiments, when the radio of the remote interface 802 wishesto gather channel statistics from the device 800 or update the masterchannel list of the radio of the device 800, the radio of the remoteinterface 802 may use system messages. Synchronization for putting thenew updated list into effect may use flags in the heartbeat messages toremove timing uncertainty.

The radio communication system may be written in C++ to be compatiblewith the messaging software. In some embodiments, a four byte radioserial number may be used to address each radio node. A hash table maybe used to provide a one-to-one translation between the device“readable” serial number string and the radio serial number. The hashtable may provide a more randomized e.g., 8-bit logical address so thatdevices or remote interfaces with similar readable serial numbers aremore likely to have unique logical addresses. In some embodiments, radioserial numbers may not have to be unique between device 800 and remoteinterfaces 802 due to the unique roles each has in the radio protocol.

The radio serial number of the remote interface 802 and the radio serialnumber of the device 800 may be included in all radio packets, in someembodiments, except for the RF Pairing Request message that may onlyinclude the radio serial number of the remote interface 802, thusensuring that only occur with the remote control assembly/infusion pumpassembly to which it is paired. The CC2510 may support a one bytelogical node address and it may be advantageous to use one byte of theradio serial number as the logical node address to provide a level offiltering for incoming packets.

The Quiet_Radio signal may be used by the UI processor of the remoteinterface 802 to prevent noise interference on the board of the remoteinterface 802 by other systems on the board. When Quiet_Radio isasserted, the radio application of the remote interface 802 may send amessage to the radio of the device 800 asserting Radio Quiet Mode for apre-determined period of time. In some embodiments, the Quiet_Radiofeature may not be required based on noise interference levels measuredon the PC board of the remote interface 802. During this period of time,the radio of the remote interface 802 may stay in Sleep Mode 2 for up toa maximum of 100 ms. The radio of the remote interface 802 may come outof Sleep Mode 2 when the Quiet_Radio signal is de-asserted or themaximum time period has expired. The UI processor of the remoteinterface 802 may assert Quiet_Radio at least one radio communication'sinterval before the event needs to be asserted. The radio of the remoteinterface 802 may inform the radio of the device 800 such thatcommunications will be shutdown during this quiet period. The periodicradio link protocol may have status bits/bytes that accommodate theQuiet_Radio feature unless Quiet_Radio is not required.

The radio software may integrate with the messaging system and radiobootloader on the same processor, and may be verified using a throughputtest. The radio software may integrate with the messaging system, SPIDriver using DMA, and radio bootloader, all on the same processor (e.g.,the TI CC2510).

In some embodiments, the radio of the remote interface 802 may beconfigured to consume no more than 32 mAh in three days (assuming onehundred minutes of fast heartbeat mode communications per day). In someembodiments, the radio of the device 800 may be configured to consume nomore than 25 mAh in three days (assuming one hundred minutes of fastheartbeat mode communications per day). However, these configurationsmay vary throughout the embodiments and in some embodiments, may be moreor less than the stated examples.

The maximum time to reacquire communications may be ≤6.1 secondsincluding connection request mode and acquisition mode, however, invarious other embodiments, the maximum time may be lower or higher. Insome embodiments, the radio of the remote interface 802 may use the fastheartbeat mode or slow heartbeat mode setting to its advantage in orderto conserve power and minimize latency to the user. The differencebetween the device 800 and the remote interface 802 entering acquisitionmode may be that the device 800 needs to enter acquisition mode oftenenough to ensure communications may be restored within the maximumlatency period. However, the remote interface 802 may change how oftento enter acquisition mode with the device 800 when in slow heartbeatmode and heartbeats are lost. In some embodiments, the radio of theremote interface 802 may have knowledge of the user GUI interaction, butthe device 800 may not.

The radio of the remote interface 802 may set the heartbeat period forboth radios. In some embodiments, the period may be selectable in orderto optimize power and link latency depending on activity. The desiredheartbeat period may be communicated in each heartbeat from the radio ofthe remote interface 802 to the radio of the device 800. This may notexclusively establish the heartbeat rate of the device 800 due to otherconditions that determine what mode to be in. When in fast heartbeatmode, the radio of the remote interface 802 may set the heartbeat periodto 20 ms if data packets are available to send or receive, thusproviding low link latency communications when data is actively beingexchanged.

When in fast heartbeat mode, the radio of the remote interface 802 mayset the heartbeat period to 60 ms four heartbeats after a data packetwas last exchanged in either direction on the radio. Keeping the radioheartbeat period short after a data packet has been sent or received mayassure that any data response packet may be also serviced using a lowlink latency. When in slow heartbeat mode, the heartbeat rate may be2.00 seconds or 6.00 second, depending upon online or offline statusrespectively. However, in various embodiments, these values may vary.

The device 800 may use the heartbeat rate set by the radio of the remoteinterface 802. The radio of the remote interface 802 may, in someembodiments, support one or more, but not limited to, the following moderequests by way of the messaging system:

-   -   Pairing Mode    -   Connection Mode    -   Acquisition Mode (includes the desired paired infusion pump        assembly 100, 100′, 400, 500 radio serial number)    -   Sync Mode—Fast Heartbeat    -   Sync Mode—Slow Heartbeat    -   RF Off Mode

The radio of infusion pump assembly 100, 100′, 400, 500 may support thefollowing mode requests via the messaging system:

-   -   Pairing Mode    -   Acquisition Mode    -   RF Off Mode

In some embodiments, the radio may use a system message to obtain thelocal radio serial number. On the remote interface 802, the radio mayget the serial number from the UI processor of the remote interface 802.The radio may use a system message to store the paired radio serialnumber.

The remote interface 802 and the radio of the device 800 may issue astatus message using the messaging system to the UI processor of theremote interface 802 and the command processor 902 in some embodimentswhenever one or more, but not limited to, the following status changes:

-   -   Online Fast: Successful connection    -   Online Fast: Change from Acquisition Mode to Fast Heartbeat Mode    -   Online Slow: Successful request change from Fast Heartbeat to        Slow Heartbeat    -   Offline: Automatic change to Search Sync mode due to lack of        heartbeat exchanges.    -   Online Fast: Successful request change from Slow Heartbeat to        Fast Heartbeat    -   Offline: Bandwidth falls below 10% in Sync Mode    -   Online: Bandwidth rises above 10% in Search Sync mode    -   Offline: Successful request change to RF Off Mode

In some embodiments, the radio configuration message may be used toconfigure the number of radio retries. This message may be sent over themessaging system. In some embodiments, the UI processor of the remoteinterface 802 will send this command to both the radio of the remoteinterface 802 and the radio the device 800 to configure these radiosettings.

In some embodiments, there may be two parameters in the radioconfiguration message: namely the number of RF retries (e.g., the valuemay be from 0 to 10); and the radio offline parameters (e.g., the valuemay be from 1 to 100 in percent of bandwidth). However, in various otherembodiments, there may be more than or less than two parameters.

The radio application on both the remote interface 802 and the device800 may have an API that allows the messaging system to configure thenumber of RF retries and radio offline parameters.

In some embodiments, one or more of, but not limited to, the followingparameters may be recommended for the radio hardware configuration:

-   -   Base Radio Specifications    -   MSK    -   250 kbps over air baud rate    -   Up to 84 channels    -   Channel spacing 1000 kHz    -   Filter bandwidth 812 kHz    -   No Manchester encoding    -   Data whitening    -   4 byte preamble    -   4 byte sync (word)    -   CRC appended to packet    -   LQI (Link Quality Indicator) appended to packet    -   Automatic CRC filtering enabled

In some embodiments, Forward Error Correction (FEC) may or may not beutilized. Although Forward Error Correction (FEC) may be used toincrease the effective signal dynamic range by approximately 3 dB, FECrequires fixed packet sizes and doubles the number of over the air bitsfor the same fixed size message, so this may not be desirable in someembodiments.

In some embodiments, the radio may function within 1.83 meters distanceunder nominal operating conditions (except in pairing mode). In someembodiments, the radio may function within 7.32 meters distance undernominal operating conditions. In some embodiments, the transmit powerlevel may be 0 dBm (except in pairing mode) and the transmit power levelin pairing mode may be −22 dBm. Since the desired radio node address ofthe device 800 may be not known by the remote interface 802 in pairingmode, in some embodiments, both the device 800 and the remote interface802 may use a lower transmit power to reduce the likelihood ofinadvertently pairing with another infusion pump assembly. However, invarious other embodiment, either the device 800 or the remote interface802 may us a lower transmit power.

In some embodiments, AES Encryption may be used for all packets but maynot be required, for example, in embodiments using the Texas InstrumentsCC2510 radio transceiver as this transceiver includes thisfunctionality. In the embodiments where AES encryption is used, fixedkeys may be utilized, as fixed keys may be desirable for many reasons,including that they provide a quick way to enable encryption withoutpassing keys. However, in some embodiments, key exchange may be providedin the device 800. In some embodiments, the fixed keys may be containedin one separate header source file with no other variables but the fixedkeys data, thus allowing for easier management of read access of thefile.

In some embodiments, the radio software may support one or more, but notlimited to, of the following eight modes:

-   -   Pairing Mode    -   RF Off Mode    -   Connection Mode    -   Acquisition Mode    -   Fast Heartbeat Mode    -   Slow Heartbeat Mode    -   Search Sync Mode    -   Sync'ed Acquisition Mode    -   all of which are graphically depicted in FIGS. 12B-12C.

Pairing may be the process of exchanging radio serial numbers betweenthe remote interface 802 and the device 800. The remote interface 802may be “paired” with the device 800 when the device 800 knows its serialnumber. The device 800 may be “paired” with the remote interface 802when the remote interface 802 knows its serial number.

In some embodiments, pairing mode (one embodiment of which isgraphically depicted in FIG. 12D) may require that four messages to beexchanged over the RF link (however, various embodiments may requiremore, less or no messages be exchanged over the RF link):

-   -   RF Pairing Request (broadcast from the remote interface 802 to        any device 800)    -   RF Pairing Acknowledge (from the device to the remote interface        802)    -   RF Pairing Confirm Request (from the remote interface 802 to the        device 800)        -   RF Pairing Confirm Acknowledge (from the device 800 to the            remote interface 802)

Additionally, the remote interface 802 may cancel the pairing process atany time using the RF pairing abort message (from the remote interface802 to the device 800. In some embodiments, pairing mode may not supportmessaging system data transfers.

In some embodiments, the radio of the device 800 may enter pairing modeupon receiving a pairing mode request message. In some embodiments, itmay be the responsibility of the supervisor processor 900 on the device800 to request the radio to enter pairing mode if there is no disposableportion attached to the device 800 and the user has pressed the switchassembly 810 of the device 800 for a predetermined amount of time, e.g.,six seconds (which may vary throughout the embodiments) to indicate tothe system that pairing mode is requested. The radio of the device 800may set the appropriate transmit power level for pairing mode. In someembodiment, the device 800 may only be paired with one the remoteinterface 802 at a time.

In some embodiment, a Near Field Communication (“NFC”) protocol may beused to identify the device 800 and remote interface 802 to be paired.For example, using NFC, the user may touch the disposable portion to theremote interface 802, while the devices are in pairing mode, and thismay trigger the pairing protocol, i.e., the device 800 and remoteinterface 802 to be paired are identified. In some embodiments, acamera, located on the remote interface 802, may be used to capture theimage of a 2 D barcodes on the device 800 and identify the device 800using this image and/or image identification. In some embodiments, thedevice 800 may include a RFID transmitter which may be used in the NPCprotocol for recognition).

In some embodiments, upon receiving the first valid RF pairing requestmessage while in pairing mode, the radio of device 800 may use theserial number of the remote interface 802 for the duration of pairingmode and respond with an RF pairing acknowledge message containing theradio serial number of the device 800.

In some embodiments, the radio of the device 800 may timeout of pairingmode automatically after a predetermined amount of time, for example,2.0±0.2 seconds, if no RF pairing request is received. In someembodiments, this time may be less than or more than 2.0±0.2 seconds. Insome embodiments, the radio of the device 800 may issue a pairingrequest received message after transmitting the RF pairing acknowledge.This message to the supervisor processor 900 will allow feedback to theuser during the pairing confirm process. The radio of the device 800 mayautomatically timeout of pairing mode in, for example, 1.0±0.1 minutesafter sending an RF pairing acknowledge unless an RF pairing confirmrequest is received. In some embodiments, this time may be less than ormore than 1.0±0.1 seconds. In some embodiments, the radio of the device800 may issue a store paired radio serial number message if an RFpairing confirm request message is received after receiving a RF pairingrequest message. This action may store the radio serial number of theremote interface 802 in the non-volatile memory of the device 800 andmay overwrite the existing pairing data for the device 800.

The radio of the device 800 may transmit an RF pairing confirmacknowledge and exit pairing mode after the acknowledgment from thestore paired radio serial number message is received. In someembodiments, this may be the default exit of pairing mode on the device800 and may result in the device 800 powering down until connection modeor paring mode entered by the user.

In some embodiments, if the radio of the device 800 exits pairing modeupon successfully receiving a pairing confirm request message, then theradio of the device 800 may revert to the newly paired remote interface802 and may send a pairing completion success message to the commandprocessor 902. In some embodiments, the radio of the device 800 may exitpairing mode upon receiving an RF pairing abort message. The radio ofthe device 800 may exit pairing mode upon receiving a pairing abortrequest message addressed to it. In some embodiments, this may allow thecommand processor 902 or the supervisor processor 900 to abort thepairing process locally on the device 800.

In some embodiments, the radio of the remote interface 802 may enterpairing mode upon receiving a pairing mode request message. In someembodiments, it may be the responsibility of the UI processor of theremote interface 802 to request that the radio enter pairing mode underthe appropriate conditions. The radio of the remote interface 802 mayset the appropriate transmit power level for pairing mode. In someembodiments, the radio of the remote interface 802 may transmit RFpairing requests until an RF pairing acknowledge is received or pairingis aborted.

In some embodiments, the radio of the remote interface 802 mayautomatically abort pairing mode if the RF pairing acknowledge messageis not received within a predetermined time, for example, 30.0±1.0seconds after entering pairing mode. However, in various embodiments,the predetermined time may be greater than or less than 30.0±1.0seconds. In some embodiments, upon receiving the first valid RF pairingacknowledge message while in pairing mode, the radio of the remoteinterface 802 may send a pairing success message to the UI processor ofthe remote interface 802 that includes the serial number of the device800 and may use that serial number for the duration of pairing mode.This message may provide a means for the UI processor of the remoteinterface 802 to have the user confirm the serial number of the desireddevice 800. In some embodiments, if the radio of the remote interface802 receives multiple responses (concerning a single pairing request)the device 800, the first valid one may be used.

In some embodiments, the radio of the remote interface 802 may onlyaccept an RF pairing confirm acknowledge messages after an RF pairingacknowledge is received while in pairing mode. The radio of the remoteinterface 802 may transmit the RF pairing confirm message upon receivinga pair confirm request message from the UI processor of the remoteinterface 802.

In some embodiments, the radio of the remote interface 802 may checkthat the device 800 confirms the pairing before adding the device 800 tothe pairing list. In some embodiments, the radio of the remote interface802 may issue a store paired radio serial number message if an RFpairing complete message is received. This action may allow the UIprocessor of the remote interface 802 to store the new serial number ofthe device 800 and provide user feedback of a successful pairing. It maybe the responsibility of the UI processor of the remote interface 802 tomanage the list of paired infusion pump assemblies. Thus, in someembodiments of the system, the system may include more than one device,and each of the more than one device may be paired with the remoteinterface 802. However, in some embodiments, it may be desirable thatone device of the paired devices, be in use with the remote interface802 at any given time. Thus, in these embodiments, once the initialpairing process is complete and the remote interface 802 includes thedevice on its list of paired devices, the user indicates to the remoteinterface 802 the device in which communication is desired for thatduration (predetermined amount of time) for use.

In some embodiments, the radio of the remote interface 802 may send anRF pairing abort message and exit pairing mode upon receiving a pairingabort request message. This may allow the UI processor of the remoteinterface 802 to abort the pairing process on both the remote interface802 and the acknowledged device 800.

In connection request mode, the radio of the remote interface 802 mayattempt to acquire each device 800 in its paired device list andretrieve its “connection ready” status. The “connection” process, oneembodiment of which is graphically depicted in FIG. 12E, in someembodiments may allow the remote interface 802 to quickly identify oneof its paired devices that may be ready to be used. The radio of theremote interface 802 may be capable of performing the connection requestmode with a plurality of devices, for example, in some embodiments, upto six paired reusable portions of infusion pumps. The connectionrequest mode may be only supported on the remote interface 802 and maybe a special form of acquisition mode. In connection request mode, theremote interface 802 may connect with the first device to respond.However, each message may be directed to a specific device serialnumber.

In some embodiments, the radio of the remote interface 802 may obtainthe latest paired device's serial number list upon entering connectionmode. The radio of the remote interface 802 may enter connection modeupon receiving a connection mode request message. It may be theresponsibility of the UI processor of the remote interface 802 torequest that the radio enter connection mode when it desirescommunications with a paired device. The radio of the remote interface802 may issue a connection assessment message to the UI processor of theremote interface 802 containing the radio serial number of the firstdevice, if any, that is “connection ready”. The radio of the remoteinterface 802 may generate the connection assessment message within apredetermined amount of time, for example, thirty seconds, of enteringconnection request mode. However, the predetermined amount of time maybe less than or more than thirty seconds in various embodiments. In someembodiments, the radio of the remote interface 802 may exit connectionrequest mode upon receipt of the connection assessment acknowledgementand transition to fast heartbeat mode. The radio of the remote interface802 may exit connection request mode upon receipt of a connectionrequest abort message from the UI processor of the remote interface 802.

On the remote interface 802, acquisition mode may be used to find aparticular paired device. In some embodiments, the radio of the remoteinterface 802 may send RF RUT (aRe yoU There) packets to the desiredpaired device. If the device receives the RF RUT message, it may respondto the radio of the remote interface 802. In some embodiments, multiplechannels may be used in the acquisition mode algorithm to improve theopportunity for the radio of the remote interface 802 to find the paireddevice.

The radio of the remote interface 802 may enter acquisition mode uponreceiving an acquisition mode request or fast heartbeat mode requestmessage while in RF Off Mode. The radio of the remote interface 802 mayenter sync'ed acquisition mode upon receiving an acquisition moderequest or fast heartbeat mode request message while in search syncmode. It may be the responsibility of the UI processor of the remoteinterface 802 to request that the radio enter acquisition mode when theRF link is off-line and the remote interface 802 desires communicationswith a device.

In some embodiments, particularly in those embodiments where the deviceis an infusion pump, the radio of the remote interface 802 may onlycommunicate with one paired infusion pump 800 (except in pairing andconnection modes). In some embodiments, when communications are lost,the UI processor of the remote interface 802 may use acquisition mode(at some periodic rate limited by the power budget) to attempt torestore communications.

In some embodiments, the device 800 may enter acquisition mode under oneor more of the following condition, although in various otherembodiments, additional conditions may trigger acquisition mode:

-   -   When in Radio Off Mode and Acquisition Mode may be requested.    -   When Search Sync Mode times out due to lack of heartbeats.

Upon entering acquisition mode, the radio of the device 800 may obtainthe serial number of the last stored paired the remote interface 802.The radio of the device 800 may only communicate with the remoteinterface 802 to which it has been “paired” (except while in the“pairing request” mode). The radio of the device 800 may transition fromacquisition mode to fast heartbeat mode upon successfully acquiringsynchronization with the remote interface 802. The acquisition mode ofthe device 800 may be capable of acquiring synchronization within 6.1seconds, which, in some embodiments, may indicate that the device 800may always be listening at least every ˜6 seconds when in acquisitionmode. However, in various embodiments, the listening may be at shorteror increased durations.

In some embodiments, data packets may be sent between, for example, apaired device 800 and the remote interface 802 when the device 800 andthe remote interface 802 are in sync mode and online. The two devicesmay sync via a heartbeat packet before data packets are exchanged. Eachradio may send data packets at known time intervals after the heartbeatexchange. The device 800 may adjust its timing to anticipate receptionof a packet. In some embodiments, the radio may support one data packetin each direction on each heartbeat. The radio may provide a negativeresponse to a fast heartbeat mode request if the radio is offline. Theradio of the remote interface 802 may change to fast heartbeat mode if asystem request for fast heartbeat mode is received while in slowheartbeat mode and the radio is online.

Upon transitioning to fast heartbeat mode from acquisition mode, theradio of the remote interface 802 may send the master channel listmessage. The master channel list may be built by the radio of the remoteinterface 802 and sent to the radio of the device 800 to allow aselection of frequency hopping channels based on historical performance.When in fast heartbeat mode or slow heartbeat mode, periodic heartbeatmessages may be exchanged between the radio of the remote interface 802and the radio of the device 800. The periodicity of these messages maybe at the heartbeat rate. The heartbeat messages may allow data packettransfers to take place and may also exchange status information. Insome embodiments, the two radios may exchange the following statusinformation, however, in other embodiments, additional information orless information may be exchanged: Quiet Mode, data availability, bufferavailability, heartbeat rate, and prior channel performance. In someembodiments, it may be a goal to keep the packet size of the heartbeatmessages small in order to conserve power. In these embodiments, theradio may provide for a maximum data packet size of eighty-two byteswhen in Sync Mode. The messaging system may be designed to supportpacket payload sizes up to, for example, sixty-four bytes. The maximumsize may be selected as an optimal trade-off between minimum messagestypes and non-fragmented messages. In some embodiments, the eighty-twobytes may be the maximum packet size of the messaging system includingpacket overhead, however, in various embodiments, this maximum packetsize may be larger or smaller.

In some embodiments, the messaging system has an API that may allow theradio protocol to send an incoming radio packet to it. The messagingsystem may also have an API that allows the radio protocol to get apacket for transmission over the radio network. The messaging system maybe responsible for packet routing between the radio protocol and the SPIport. Data packets may be given to the messaging system for processing.The messaging system may have an API that allows the radio protocol toobtain a count of the number of data packets waiting to be sent over theradio network. The radio protocol may query the messaging system on eachheartbeat to determine if data packets are available to send over theradio network. It may be desirable for the software to check theavailability of a message just before the heartbeat is sent to minimizeround trip message latency.

The radio protocol may be capable of buffering one incoming radio datapacket and passing the packet to the messaging system. In someembodiments, the radio protocol may send the data packet to themessaging system upon receipt of the data packet. The message system maybe responsible for routing radio data packets to the proper destinationnode. The radio protocol may be capable of buffering one packet from themessaging system.

The radio protocol may be responsible for acknowledging receipt of validdata packets over the RF link via an RF ACK reply packet to the sendingradio. The RF ACK packet may contain the source and destination radioserial numbers, RF ACK command identification, and sequence number ofthe data packet being acknowledged.

In some embodiments, the radio transmitting a radio data packet mayretransmit that radio data packet on the next heartbeat with the samesequence number if an RF ACK is not received and the retry count iswithin the maximum RF retries allowed. If interference corrupts atransmission on a particular frequency, in some embodiments, an RF retryallows the same packet to be retransmitted at the next opportunity at adifferent frequency. The sequence number provides a means of uniquelyidentifying the packet over a short time window. The number of radiopacket retries may be configurable using the radio configurationcommand. Allowing more retries may increase the probability of a packetbeing exchanged but introduces more latency for a round trip messages.The default number of radio retries at power up may be ten (i.e., themaximum transmission attempts before dropping the message). However,this maximum number may vary in various embodiments.

In some embodiments, a one byte (modulo 256) radio sequence number maybe included in all radio data packets over the RF link. Since the radiomay be responsible for retrying data packet transmission if notacknowledged, the sequence number may provide a way for the two radiosto know if a data packet is a duplicate. The transmitted sequence numbermay be incremented for each new radio data packet and may be allowed torollover. When a data packet is successfully received with the samesequence number as the previous successfully received data packet (andin the same direction), the data packet may be ACK′d and the receiveddata packet discarded. This may remove duplicate packets generated bythe RF protocol before they are introduced into the network. Note thatit may be possible that multiple data packets in a row may need to bedropped with the same sequence number under extreme situations.

In some embodiments, if a heartbeat is missed, the radio of the remoteinterface 802 and the radio of the device 800 may attempt to send andlisten respectively for subsequent heartbeats. The radio of the remoteinterface 802 and the radio of the device 800 may automatically changefrom fast heartbeat mode or slow heartbeat mode to search sync mode ifheartbeats are missed for two seconds. This may minimize powerconsumption when the link is lost by allowing the radios to continue touse their synchronization information, as two seconds allows sufficienttime to hop through all channels.

In some embodiments, the radio may be considered online while in thefollowing modes:

-   -   Fast Heartbeat mode    -   Slow Heartbeat mode

For, in some embodiments, these may be the only conditions where themessaging system traffic may be exchanged. All other conditions may beconsidered offline.

The radio may initialize to radio off mode at the start of codeexecution from reset. When code first executes on the radio processor,the initial state may be the radio off mode to allow other processors toperform self-tests before requesting the radio to be active. Thisrequirement does not intend to define the mode when waking from sleepmode. The radio may cease RF communications when set to radio off mode.On the remote interface 802, this mode may be intended for use on anairplane, or in airplane mode, to suppress RF emissions. Since thedevice 800 only responds to transmissions from the remote interface 802(which will have ceased transmitting in airplane mode), radio off modemay only be used on the device 800 when charging.

In some embodiments, the command processor 902 may be informed ofairplane mode and that, therefore, the RF was intentionally turned offon the remote interface 802 so that it does not generate walk-awayalerts. However, this may be completely hidden from the radio of thedevice 800.

In some embodiments, the radio of the remote interface 802 and the radioof the device 800 may periodically attempt to exchange heartbeats inorder to reestablish data bandwidth while in search sync mode. The radioof the remote interface 802 may transition to radio off mode after apredetermined period of time, for example, twenty minutes, of searchsync mode with no heartbeats successfully exchanged.

In some embodiments, the radio of the device may transition toacquisition mode after a predetermined amount of time, for example,twenty minutes, of search sync mode with no heartbeats successfullyexchanged. In some embodiments, listening during pre-agreed time slotsmay be the most efficient use of power for the device 800 tore-establish the RF link. After a loss of communications, the crystaltolerance and temperature drift may make it necessary to expand thereceive window of the device 800 over time. Staying in search sync modefor extended periods (e.g., 5-20 minutes) after communications loss maycause the instantaneous power consumed to exceed the average powerbudgeted for the radio of the device 800. The radio of the remoteinterface 802 may not be forced to expand its window, so staying insearch sync mode may be very power efficient. Acquisition mode mayconsume more power for the remote interface 802. In some embodiments,twenty minutes may be used as a compromise to balance power consumptionon both the radio of the remote interface 802 and the radio of thedevice 800, however, this time may vary with the embodiment.

The radio of the remote interface 802 and the radio of the device 800may transition to slow heartbeat mode if they successfully exchange apredetermine percentage of a group of heartbeats, for example, three ofthe last five heartbeats. Then, at a predetermined interval, forexample, approximately every six seconds, a burst of five (or more, orless, or less, depending on the embodiment) heartbeats may be attempted.If a predetermined percentage of these, for example, three of these aresuccessful, the bandwidth may be assumed to be sufficient to transitionto slow heartbeat mode. The radio of the device 800 may be acquirablewhile in search sync mode with a latency of, for example, 6.1 seconds,however, this latency may vary with embodiments. In this embodiments,this may imply that the device 800 may always be listening at leastevery ˜6 seconds when in search sync mode.

Radio protocol performance statistics may be desired to promotetroubleshooting of the radio and to assess radio performance. In someembodiments, the following radio performance statistics may bemaintained by the radio protocol in a data structure, however, these aremerely one embodiment and these may vary throughout the embodiments.Some embodiments may not use statistics or may use more, less ordifferent statistics:

NAME SIZE DESCRIPTION TX Heartbeat Count 32 Bits Total transmittedheartbeats RX Heartbeat Count 32 bits Total valid received heartbeatsCRC Errors 16 bits Total packets received over the RF link which weredropped due to bad CRC. This may be a subset of RX Packets Nacked. FirstRetry Count 32 bits Total number of packets which were successfullyacknowledged after 1 retry Second Retry Count 32 bits Total number ofpackets which were successfully acknowledged after 2 retries Third RetryCount 32 bits Total number of packets which were successfullyacknowledged after 3 retries Fourth Retry Count 32 bits Total number ofpackets which were successfully acknowledged after 4 retries Fifth RetryCount 16 bits Total number of packets which were successfullyacknowledged after 5 retries Sixth Retry Count 16 bits Total number ofpackets which were successfully acknowledged after 6 retries SeventhRetry Count 16 bits Total number of packets which were successfullyacknowledged after 7 retries Eighth Retry Count 16 bits Total number ofpackets which were successfully acknowledged after 8 retries Ninth RetryCount 16 bits Total number of packets which were successfullyacknowledged after 9 retries Tenth Retry Count 16 bits Total number ofpackets which were successfully acknowledged after 10 retries DroppedRetry Count 16 bits Total number of packets which were dropped aftermaximum retries attempts Duplicate Packet Count 16 bits Total number ofreceived packets dropped due to duplicate packet 1 to 5 Missed Fast ModeHops 16 bits Count of 1 to 5 consecutive missed hops in Fast mode (i.e.not received) 6 to 16 Missed Fast Mode Hops 16 bits Count of 6 to 16consecutive missed hops in Fast mode. 17 to 33 Missed Fast Mode Hops 16bits Count of 17 to 33 consecutive missed hops in Fast mode 34+ MissedFast Mode Hops 16 bits Count of 34 or more consecutive missed hops inFast mode 1 to 2 Missed Slow Mode Hops 16 bits Count of 1 to 2consecutive missed hops in Slow mode (i.e. not received) 3 to 5 MissedSlow Mode Hops 16 bits Count of 3 to 5 consecutive missed hops in Slowmode 5 to 7 Missed Slow Mode Hops 16 bits Count of 5 to 7 consecutivemissed hops in Slow mode 8+ Missed Slow Mode Hops 16 bits Count of 8 ormore consecutive missed hops in Slow mode Destination Radio SerialNumber 16 bits Count of received packets in which the destination madeit Mismatch past the hardware filtering but does not match this radio'sserial number. This may be not an error but indicates that the radio maybe waking up and receiving (but not processing) packets intended forother radios Total Walkaway Time (minutes) 16 bits Total Walkaway Events16 bits Together with total walkaway time provides an average walkawaytime Number of Pairing Attempts 16 bits Total Time in Acquisition Mode16 bits (Device 800 Only) Total Acquisition Mode Attempts 16 bitsSuccessful Acquisition Count 16 bits Count of transitions (the RemoteInterface 802 Only) from Connect or Acquisition Mode to Fast HeartbeatMode Requested Slow Heartbeat Mode 16 bits Transitions Automatic SlowHeartbeat Mode 16 bits Transitions Radio offline messages sent 16 bitsRadio online messages sent 16 bits

In some embodiments, a #define DEBUG option (compiler option) may beused to gather one or more of the following additional radio performancestatistics per each channel (16 bit numbers), however, in various otherembodiments, additional information may also be gathered:

-   -   Number of missed hops    -   CCA good count    -   CCA bad count    -   Average RSSI (accumulated for good RX packets only)    -   Dropped from Frequency Hop List count    -   Acquisition Mode count (found pair on this channel)

In some embodiments, the debug option may be used to gather engineeringonly statistics. If processor performance, power, and memory allow, itmay be desirable to keep this information at runtime. The radiostatistics may be made available to the messaging system.

In some embodiments, link quality may be intended to be used/viewable onthe remote interface 802 to provide a bar indicator, similar to a cellphone, of the radio link quality. Link quality may be made available toboth the remote interface 802 and the device 800. In some embodiments,the link quality status may consist of a one byte indicator of thequality of the radio link.

In some embodiments, the radio may change frequency for each heartbeat.An adaptive pseudo random frequency hopping algorithm may be used forsync mode and heartbeat attempts in search sync mode. In someembodiments, it may be a goal to use, for example, sixty-four channelsfor frequency hopping. However, in other embodiments using frequencyhopping, more than or less than sixty-four channels may be used. In someembodiments, an algorithm may be developed to adaptively generate achannel list on the remote interface 802 for frequency hopping. Theradio of the remote interface 802 may build, maintain, and distributethe master channel list. In some embodiments, prior channel statisticsand historical performance information may be obtained from the radio ofthe device 800 by the radio of the remote interface 802 using themessaging system as needed to meet performance requirements. By buildingthe channel list from the perspective of both the device 800 and theremote interface 802, the radio interference environment of both unitsmay be considered. The radios may adaptively select hopping channels tomeet the round trip message latency, while operating in a desirable RFenvironment.

Referring now also to FIG. 13 , in some embodiments, the system mayinclude at least two reusable portions 1300, 1308 of an infusion pumpand at least one disposable portion 1310 of the infusion pump. In someembodiments, the reusable portions 1300, 1308 include a rechargeablebattery 532. In some embodiments, the two disposable portions may bepaired to the same remote interface(s) which may include the embodimentshown in FIG. 13 as 1302 and/or any one or more shown in FIGS. 6-8 as600, 700, 802. In some embodiments, a user may connect a reusableportion 1308 to a disposable portion 1310 by, as described above,rotating in the direction of the arrow 1316 the reusable portion 1308while lined up with the disposable portion 1310 to connect the reusableportion 1308 with the disposable portion 1310. The second reusableportion 1300 may be docked onto the recharge station 1304 by connectingto the recharge station 1304 through electric contacts (not shown) inrecharge area 1306. While the user is sleeping or otherwise remaining ina single area for an extended period of time, for example, three hours,the remote interface 1302 may be recharged by docking the remoteinterface 1302 onto the recharge station 1304 by connecting to therecharge station 1304 through electric contacts (not shown) in slot1318. In some embodiments, the electric contract may be a USB plug whichmay be configured to couple with the remote interface 1302 when theremote interface 1302 is disposed in the slot 1318. The USB plug mayallow for data transfer to/from the remote interface 1302 as well ascharging of the remote interface 1302. In some embodiments, a user mayuse one reusable portion 1308 whilst recharging the second reusableportion 1300.

Referring now to FIGS. 14A-14E, another embodiment of the infusion pumpsystem is shown. The system may include a remote interface 1402, onereusable portion 1400, a second reusable portion 1406, at least onedisposable portion 1408 and a charging station 1404 to charge the remoteinterface 1402 and/or to charge one or the two disposable portions 1400,1406. In some embodiments, the charging station may be any chargingstation shown in, or similar to any charging station shown and/ordescribed in one or more of the following: U.S. Publication No.US-2007-0228071 published Oct. 4, 2007 and U.S. Publication No.US-2009-0299277 published Dec. 3, 2009 and U.S. patent application Ser.No. 12/981,283, filed Dec. 29, 2010, and entitled Infusion PumpAssembly, which are hereby incorporated herein by reference in theirentireties. As discussed above with respect to FIG. 13 , the chargingstation may include a USB plug which may be configured to couple withthe remote interface 1402 when the remote interface 1402 is disposed inthe slot 1414. The USB plug may allow for data transfer to/from theremote interface 1402 as well as charging of the remote interface 1402.

Referring now to FIGS. 15A-15B, another embodiment of the chargingstation 1500 is shown. As shown, in some embodiments, the chargingstation 1500 may include a charging area for a reusable portion 1504 anda charging area for the remote interface which may include a USB plug1502. In some embodiments, the charging station 1500 may include a USBport 1508, and in some embodiments, may include a mini-USB port,allowing for the charging station 1500 to receive power, in someembodiments, for charging the reusable portion and/or the remoteinterface through a USB 1506. Additionally and/or alternatively the USBport 1508 may be configured for data transfer to/from a remote interfaceand/or a reusable portion and/or by connection to a computer or otherdevice and/or other computer-type apparatus. In embodiments including aUSB port, whilst the remote interface is being charged, the system maycall to a personal computer and/or web portal to check for updatedsoftware and if there is updated software available, may downloadsoftware updates. These updates may then be transferred to the reusableupon pairing.

Referring now also to FIGS. 16A-16F, as discussed above, reusableportion 1602 may include battery 1632, e.g., which may include arechargeable battery. The battery charger 1600 may be configured torecharge battery 1632. Battery charger 1600 may include housing 1602having top plate 1604. Top plate 1604 may include one or more electricalcontacts 1606, generally, configured to be electrically coupled toelectrical contacts 1634 of reusable housing assembly 1602. Electricalcontacts 1606 may include, but are not limited to, electrical contactpads, spring biased electrical contact members, or the like.Additionally, top plate 1604 may include alignment tabs 1608, 1610,which may be configured to mate with openings 1636, 1638 in base plate1618 of reusable housing assembly 1602 (e.g., as shown in FIG. 5C). Thecooperation of alignment tabs 1608, 1610 and openings 1636, 1638 mayensure that reusable housing assembly 1602 is aligned with batterycharger 1600 such that electrical contacts 1606 of battery charger 1600may electrically couple with electrical contacts 1634 of reusablehousing assembly 1602.

The battery charger 1600 may be configured to releasably engage thereusable portion 1602. For example, in a similar manner as disposablethe disposable portion, the battery charger 1600 may include one or morelocking tabs (e.g., locking tabs 1612, 1614). The locking tabs (e.g.,locking tabs 1612, 1614) may be engaged by tabs 1642, 1644, 1646, 1648of locking ring assembly 1606. As such, the reusable portion 1602 may bealigned with the battery charger 1600 (by way of the alignment tabs1608, 1610) with the locking ring 1606 in a first, unlocked position, asshown in FIG. 16C. The locking ring 1606 may be rotated relative to thebattery charger 1600 in the direction of the arrow 1616 to releasablyengage the tabs 1642, 1644, 1646, 1648 of the locking ring 1606 with thelocking tabs (e.g., locking tabs 1612, 1614) of the battery charger1600, as shown in FIG. 16D.

In some embodiments, battery charger 1600 may include a recessed region1618, e.g., which may, in some embodiments, provide clearance toaccommodate the reusable portion's 1602 pumping and valving components.Referring also to FIGS. 16E-16F, the battery charger 1600 may provideelectrical current to the electrical contacts 1606 (and thereby to thereusable portion 1602 by way of the electrical contacts 1634) for therecharging battery 1632 of the reusable portion 1602. In someembodiments, when a signal indicative of a fully engaged reusableportion is not provided, current may not be provided to the electricalcontacts 1606. According to such an embodiment, the risk associated withan electrical short circuit (e.g., resulting from foreign objectscontacting the electrical contacts 1606) and damage to the reusableportion 1602 (e.g., resulting from improper initial alignment betweenthe electrical contacts 1606 and the electrical contacts 1634) may bereduced. Additionally, in some embodiments, the battery charger 1600 maynot unnecessarily draw current when the battery charger is not chargingthe reusable portion 1602. Still referring to FIGS. 16E-16F, the batterycharger 1600 may include a lower housing portion 1624 and top plate1604. The printed circuit board 1622 (e.g., which may include electricalcontacts 1606) may be disposed within a cavity included between the topplate 1604 and the lower housing portion 1624.

Still referring to FIGS. 16A-16F, in some embodiments, the batterycharger 1600 may include a USB plug 1650 which may be configured tocouple with a wall charger and/or a computer and/or a personal computerand/or with a remote interface. The USB plug 1650 may allow for datatransfer to/from the computer/remote interface 1402 as well as providingpower to the charging of the reusable portion 1602 using the batterycharger 1600.

Referring also to FIG. 17 , there is shown one illustrative example ofthe manner in which the various parts of the infusion pump system areconnected/communicate with one another. For example, battery charger1704 may be coupled to computing device 1700 (which, in someembodiments, may be a personal computer or any device that may be usedin a similar fashion as a personal computer, for example, but notlimited to, a tablet) by way of bus translator 1702, which converts, forexample, and in some embodiments, RS232 formatted data to e.g., I2Cformatted data. Bus translator 1702 may execute a pass-through programthat effectuates the above-described translation. Battery charger 1704may be coupled to the radio processor 1718 by way of electrical contacts1606 (described above). Radio processor 1718 may then be coupled tosupervisor processor 900 and command processor 902 via e.g., an RS232bus. The Radio processor 1718 may, in some embodiments, execute anupdate program that allows radio processor 1718 to control/orchestratethe updating of the flash memories accessible by supervisor processor900 and command processor 902. Accordingly, through the use of theabove-described coupling, software updates obtained by computing device1700 may be uploaded to flash memory (not shown) accessible bysupervisor processor 900 and command processor 902. The above-describedsoftware updates may, in some embodiments, be command line program thatmay be automatically invoked by a script process.

Referring now to FIG. 18 and FIG. 19 , two embodiments of communicationbetween device(s), the remote interface and a personal computer (which,in some embodiments has access to one or more web portals and/or one ormore secure web portals) are shown. In FIG. 18 , a remote interface 1800is in communication with an infusion pump 1802 and two other devices,which, in some embodiments, may include a blood glucose meter 1806 and acontinuous glucose monitor sensor/transmitter 1804. In some embodiments,the communication is wireless communication and may be using RFcommunication, for example, RF communication protocols as describedabove and/or may use BLUETOOTH/BLUETOOTH Low Energy or othernon-proprietary protocols. In some embodiments, the remote interface1800 is in wireless communication with a personal computer 1808,however, in some embodiments, the remote interface 1800 may be connectedto the personal computer 1808 by way of a USB connection and/or otherwired connection. In some embodiments, the remote interface 1800 andpersonal computer 1808 may be in communication by way of a web/internetconnection 1810 and or by way of the remote interface 1800 uploadinginformation to the internet and the personal computer 1808 downloadingthe information from the internet. In some embodiments, the remoteinterface 1800 and personal computer 1808 may be in communication by wayof a wired and/or infrared (“IR”) connection 1810 i.e., by way of theremote interface 1800 uploading information to the personal computer1808.

In FIG. 19 , a remote interface 1900 is in communication with aninfusion pump 1902. The infusion pump 1902 is in communication with twoother devices, which, in some embodiments may include a blood glucosemeter 1906 and/or a continuous glucose monitor sensor/transmitter 1904,and in some embodiments, may be two continuous glucose monitor sensors.In some embodiments, the communication is wireless communication and maybe using RF communication, for example, RF communication protocols asdescribed above and/or may use BLUETOOTH or other non-proprietaryprotocols, including but not limited to, low energy BLUETOOTH/BLUETOOTHLow Energy. In some embodiments, the infusion pump 1902, which is inwireless communication with the remote interface 1900, may communicatethe information received from the two devices 1904, 1906, to the remoteinterface 1900. The remote interface 1900 therefore serves as the visualUI as the remote interface 1900, in some embodiments, includes display.In some embodiments, the remote interface 1900 is in wirelesscommunication with a personal computer 1908 (which in some embodiments,has access to at least one web portal and/or secure web portal),however, in some embodiments, the remote interface 1900 may be connectedto the personal computer 1908 by way of a USB connection and/or otherwired connection. In some embodiments, the remote interface 1900 andpersonal computer 1908 may be in communication by way of a web/internetconnection 1910 and or by way of the remote interface 1900 uploadinginformation to the internet and the personal computer 1908 downloadingthe information from the internet.

With respect to both FIGS. 18 and 19 , although shown are three devicesin communication, either directly or indirectly, with a remoteinterface, the system is not limited to three devices, and in someembodiments, may include more than three devices. Additionally, in someembodiments, the system may include one device in communication with theremote interface 1900. Also, although one personal computer isillustrated in FIGS. 18 and 19 , in other embodiments, one or morepersonal computer may be used to receive information from a remoteinterface. Additionally, as discussed above with respect to the batterycharger and charging station, in some embodiments, the infusion pumpand/or the remote interface may be connected to a charging station andmay upload and/or download and/or communicated with the personalcomputer by way of a USB connection.

Referring now also to FIG. 35A, in some embodiments, the remoteinterface 3500 is in communication with an infusion pump 3502. In someembodiments, the remote interface 3500 may be any device, including, butnot limited to, a SMARTWATCH, for example, as manufactured to SONYCorporation, Tokyo, Japan, or other similar type devices, which may bereferred to as a “mini-remote interface”. In some embodiments, themini-remote interface may include one or more user inputs which includesany mechanism by which a user and/or other operator/caregiver of thedevice and/or remote interface may control a function of the deviceand/or remote interface. User inputs may include one or more mechanicalarrangements (e.g., switches, pushbuttons, jogwheel(s)), electricalarrangements (e.g., a slider, touch screen), wireless interfaces forcommunication with a remote interface (e.g., radio frequency (“RF”),infrared (“IR”), BLUETOOTH, BLUETOOTH LOW ENERGY, WiFi, ZIGBEE, XB, WiFiad hoc, White Space, Ultra wide band, Ant, and/or wireless USB),acoustic interfaces (e.g., with speech recognition), computer networkinterfaces (e.g., USB port), light/light wave image including, but notlimited to, camera input and/or images captured using a camera), soundwave and/or other types of interfaces.

In some embodiments, the mini-remote interface may include all or aportion of the functionality described above with respect to the remoteinterface. In some embodiments, therefore, the mini-remote interface mayprovide all of the same functionality (and additional in someembodiments) as described above with respect to the remote interface andmay pair, etc., with the infusion pump in some embodiments, as describedabove.

Referring now also to FIG. 35B, in some embodiments, the mini-remoteinterface 3500 is in communication with an infusion pump 3502, and insome embodiments, may also be in communication with additional devices,including but not limited to, medical devices, which, in someembodiments, may include one or more devices, which, in someembodiments, may include at least one blood glucose meter 3506 and/or atleast one continuous glucose monitor sensor/transmitter 3504. In variousother embodiments, other devices may also be in communication with themini-remote interface 3500. In some embodiments, the communication iswireless communication and may be using an RF communication protocol,for example, RF communication protocols as described above and/or mayuse BLUETOOTH/BLUETOOTH Low Energy or other non-proprietary protocols.In some embodiments, the communication may be the same between eachdevice, and in some embodiments, the communications may differ betweeneach device. In some embodiments, in addition to the communicationprotocols listed above, one or more of, but not limited to, thefollowing communications protocols may be used: WiFi, ZIGBEE, XB, WiFiad hoc, White Space, Ultra wide band, Ant, and/or wireless USB. In someembodiments, the communication may be the same between each device, andin some embodiments, the communications may differ between each device.In some embodiments, the mini-remote interface 3500 is in wirelesscommunication with a personal computer 3508, however, in someembodiments, the remote interface 3500 may be connected to the personalcomputer 3508 by way of a USB connection and/or other wired connection.In some embodiments, the mini-remote interface 3500 and personalcomputer 3508 may be in communication by way of a web/internetconnection 3510 and or by way of the mini-remote interface 3500uploading information to the internet and the personal computer 3508downloading the information from the internet. In some embodiments, theremote interface 3500 and personal computer 3508 may be in communicationby way of a wired and/or infrared (“IR”) connection 3510 i.e., by way ofthe mini-remote interface 3500 uploading information to the personalcomputer 3508. In some embodiments, the communication between themini-remote interface 3500 and the infusion pump 3502 is two-waycommunication. In some embodiments, the communication between themini-remote interface 3500 and the personal computer 3508 is one-way,i.e., the mini-remote interface 3500 may communicate to the personalcomputer 3508 (and/or internet), however, the personal computer 3508(and/or internet) may not communicate to the mini-remote interface. Thismay be beneficial for many reasons, including, but not limited to,controlling the information that is uploaded to the mini-remoteinterface 3500 which may protect the mini-remote interface 3500 fromviruses and/or undesirable and/or incorrect information being uploadedonto the mini-remote interface 3500. However, in various embodiments,the communication between one or more of the various devices 3500, 3504,3506, 3602, 3510, 3508 may be either one way or two way, and in someembodiments, the communications may be one way for some communication ofpredefined types or categories of information and may be two way forother types or categories of information. This may be desirable for manyreasons, including but not limited to, limiting the communication of,e.g., therapy critical information to one way communication between aproprietary and/or secure device and another device.

Referring now also to FIG. 35C, in some embodiments, the mini-remoteinterface 3500 is in communication with an infusion pump 3502, and insome embodiments, may also be in communication with additional devices,including but not limited to, medical devices, which, in someembodiments, may include one or more devices, which, in someembodiments, may include at least one blood glucose meter 3506 and/or atleast one continuous glucose monitor sensor/transmitter 3504. In someembodiments, the mini-remote interface 3500 may also be in communicationwith a remote interface 3512, which may be any remote interface,including, but not limited to, a Smartphone, for example, an ADROID®Smartphone. In some embodiments of this embodiment, the remote interface3512 may include one-way communication between the mini-remote interface3500 and the remote interface 3512. Thus, in these embodiments, theremote interface 3512 may receive and display information related to theone or more devices/medical devices 3502, 3504, 3506 in which are incommunication with the mini-remote interface 3500, however, the remoteinterface 3512 may not control the one more devices 3502, 3504, 3506,nor control the mini-remote interface 3500, nor send information to themini-remote interface 3500. In some embodiments, therefore, the remoteinterface 3512 may be used as an adjunct user interface, including theability to display information, for example, graphs and logbookinformation, in a larger format for easier viewing by the user. In someembodiments, the remote interface 3512 may be a Smartphone that may beused as a phone, however, may also include an application that allowsfor the mini-remote interface 3500 to send information to the remoteinterface 3512 to present the information to the user in a graphic richformat. Thus, in this embodiment, the mini-remote interface 3500controls the infusion pump 3502, and also receives information from theother devices 3504, 3506, and is the only device in the system that maysend commands and/or control the infusion pump 3502, wherein saidcontrol includes, but is not limited to, one or more of the following:programming/commanding the delivery of a bolus and/or programming anddelivering basal and/or programming/commanding any therapy relatedcommand, including, but not limited to, changing therapy or commandingthe delivery of therapy. In some embodiments of this embodiment of thesystem, the mini-remote interface 3500 may also communicate with andsend information to a personal computer 3508 and/or the internet. Insome embodiments of this embodiment of the system, the remote interface3512 may also display alarms, alerts, etc., and show the status of theinfusion pump 3502 and/or other devices 3504, 3506. In some embodiments,the mini-remote interface 3500 may send data to the remote interface3512 at regular/programmable intervals, for example, every 2 minutes,however, the intervals may be any interval desired. In some embodiments,the mini-remote interface 3500 may send data to the remote interface3512 when commanded by the user. In some embodiments, information thatis programmed by the user/caregiver into the mini-remote interface 3500may be shared by the mini-remote interface 3500 to other devices 3512,3504, 3506 in the system. This information may include, but is notlimited to, a blood glucose reading, e.g., a reading from the bloodglucose meter that is not otherwise in wireless communication with themini-remote interface 3500.

In various embodiments, the mini-remote interface 3500 may pair, forexample, with the infusion pump 3502, and or the various devices 3504,3506 and/or the remote interface 3512, using any one or more of theprotocols described above. However, in various embodiments, one or moredevices 3504, 3506, 3512 may pair with the mini-remote interface 3500using standard BLUETOOTH pairing protocols, including BLUETOOTH LowEnergy protocols. In some embodiments, one or more devices 3504, 3506,3512 may pair with the mini-remote interface 3500 using Near FieldCommunication (“NFC”) protocol, for example, the devices would share aprivate key and, use NFC to receive a real time key. In someembodiments, the network range may be limited during pairing. In someembodiments, the network range may be limited during pairing and one ormore other types of transmissions (which may be preprogrammed in someembodiments and may include, but is not limited to, changes in therapyand/or commands for therapy and/or delivery commands and/or changes indelivery commands), otherwise, may resume regular transmissions. In someembodiments, the network range may be limited during all transmissions,including, but not limited to, pairing. Various other embodiments ofpairing that may be used between any two or more of the devices invarious embodiments of the system are described above and below.

In some embodiments, the communication is wireless communication and maybe using RF communication, for example, RF communication protocols asdescribed above and/or may use BLUETOOTH/BLUETOOTH Low Energy or othernon-proprietary protocols and/or may include, but is not limited to, oneor more of the following protocols: WiFi, ZIGBEE, XB, WiFi ad hoc, WhiteSpace, Ultra wide band, Ant, and/or wireless USB. In some embodiments,the communication may be the same between each device, and in someembodiments, the communications may differ between each device. In someembodiments, the mini-remote interface 3500 is in wireless communicationwith a personal computer 3508, however, in some embodiments, the remoteinterface 3500 may be connected to the personal computer 3508 by way ofa USB connection and/or other wired connection. In some embodiments, themini-remote interface 3500 and personal computer 3508 may be incommunication by way of a web/internet connection 3510 and or by way ofthe mini-remote interface 3500 uploading information to the internet andthe personal computer 3508 downloading the information from theinternet. In some embodiments, the remote interface 3500 and personalcomputer 3508 may be in communication by way of a wired and/or infrared(“IR”) connection 3510 i.e., by way of the mini-remote interface 3500uploading information to the personal computer 3508. In someembodiments, the communication between the mini-remote interface 3500and the infusion pump 3502 is two-way communication. In someembodiments, the communication between the mini-remote interface 3500and the personal computer 3508 is one-way, i.e., the mini-remoteinterface 3500 may communicate to the personal computer 3508 (and/orinternet), however, the personal computer 3508 (and/or internet) may notcommunicate to the mini-remote interface. This may be beneficial formany reasons, including, but not limited to, controlling the informationthat is uploaded to the mini-remote interface 3500 which may protect themini-remote interface 3500 from viruses and/or undesirable and/orincorrect information being uploaded onto the mini-remote interface3500. In any one or more of the embodiments described above, in someembodiments, the mini-remote interface 3500 may include two or moreradios with the ability to communicate by way of BLUETOOTH Low Energyand/or BLUETOOTH High Energy and/or by way of a low energy protocol anda high energy protocol. For example, in some embodiments, themini-remote interface 3500 may communicate using a low power protocolradio with the infusion pump 3502 and a high energy BLUETOOTH radio orhigh power protocol radio with the remote interface 3512. Various otherembodiments of pairing that may be used between any two or more of thedevices in various embodiments of the system are described above andbelow.

Still referring to FIG. 35D, in some embodiments, the remote interface3512 may be used to control one or more devices/medical devices 3502,3504, 3506, however, in some embodiments, the remote interface 3512 mustcommunication via the mini-remote interface 3500. Thus, the mini-remoteinterface 3500 serves as a security “firewall”, i.e., a securitybarrier, thus only the mini-remote interface 3500 may communicatedirectly with the infusion pump 3502 and/or other devices/medicaldevices 3504, 3506. Also, the infusion pump 3502 and/or otherdevices/medical devices 3504, 3506, in some embodiments, onlycommunicate directly with the mini-remote interface 3500. In someembodiments of this embodiment, the mini-remote interface 3500 maycommunicate the information received from the infusion pump 3502 and/orother devices/medical devices 3504, 3506 to the internet and/or personalcomputer 3508 using the connection 3510.

Referring now also to FIG. 35E, in some embodiments, the mini-remoteinterface 3500 and a remote interface 3512 may each be used to controlan infusion pump 3502 and/or one or more additional device/medicaldevices 3504, 3506. In some embodiments of this embodiment of thesystem, the mini-remote interface 3500 may “trump” and therefore, if theremote interface 3512 and the mini-remote interface 3500 weresimultaneously both within communication distance with the infusion pump3502 and/or the one or more devices/medical devices 3504, 3506, then themini-remote interface 3500 would be the device that may communicate withthe infusion pump 3502 and/or the one or more devices/medical devices3504, 3506. In some embodiments, the mini-remote interface 3500 and theremote interface 3512 may communicate and synchronize information atpre-programmed intervals and/or when within a pre-programmedcommunication distance, for example, when the mini-remote interface 3500and the remote interface 3512 recognize that they are withincommunication distance and/or an interval of time has passed since thelast synchronization, the mini-remote interface 3500 and the remoteinterface 3512 may synchronize using a synchronization protocol whichmay be any synchronization protocol. The mini-remote interface 3500 andthe remote interface 3512 may also pair using the various protocolsdescribed and discussed herein.

In some embodiments, the communication is wireless communication and maybe using RF communication, for example, RF communication protocols asdescribed above and/or may use BLUETOOTH/BLUETOOTH Low Energy or othernon-proprietary protocols and/or may include, but is not limited to, oneor more of the following protocols: WiFi, ZIGBEE, XB, WiFi ad hoc, WhiteSpace, Ultra wide band, Ant, and/or wireless USB. In some embodiments,the communication may be the same between each device, and in someembodiments, the communications may differ between each device. In someembodiments, the mini-remote interface 3500 is in wireless communicationwith a personal computer 3508, however, in some embodiments, the remoteinterface 3500 may be connected to the personal computer 3508 by way ofa USB connection and/or other wired connection. In some embodiments, themini-remote interface 3500 and personal computer 3508 may be incommunication by way of a web/internet connection 3510 and or by way ofthe mini-remote interface 3500 uploading information to the internet andthe personal computer 3508 downloading the information from theinternet. In some embodiments, the remote interface 3500 and personalcomputer 3508 may be in communication by way of a wired and/or infrared(“IR”) connection 3510 i.e., by way of the mini-remote interface 3500uploading information to the personal computer 3508. In someembodiments, the communication between the mini-remote interface 3500and the infusion pump 3502 is two-way communication. In someembodiments, the communication between the mini-remote interface 3500and the personal computer 3508 is one-way, i.e., the mini-remoteinterface 3500 may communicate to the personal computer 3508 (and/orinternet), however, the personal computer 3508 (and/or internet) may notcommunicate to the mini-remote interface. This may be beneficial formany reasons, including, but not limited to, controlling the informationthat is uploaded to the mini-remote interface 3500 which may protect themini-remote interface 3500 from viruses and/or undesirable and/orincorrect information being uploaded onto the mini-remote interface3500. In any one or more of the embodiments described above, in someembodiments, the mini-remote interface 3500 may include two or moreradios with the ability to communicate by way of BLUETOOTH Low Energyand/or BLUETOOTH High Energy and/or by way of a low energy protocol anda high energy protocol. For example, in some embodiments, themini-remote interface 3500 may communicate using a low power protocolradio with the infusion pump 3502 and a high energy BLUETOOTH radio orhigh power protocol radio with the remote interface 3512. Various otherembodiments of pairing that may be used between any two or more of thedevices in various embodiments of the system are described above andbelow.

Referring now to FIG. 36 , one embodiment of the various embodiments ofthe system is shown. In this embodiment, the system 3600 includes aninfusion pump 3602 a remote interface 3604, a continuous glucosemonitor/transmitter 3606 and a blood glucose meter 3608. In thisembodiment, the various devices communicate using a BLUETOOTH Low Energy(BTLE) protocol. Also, in this embodiment, the infusion pump 3602 andthe remote interface 3604 communicate using two way communications. Inthis embodiment, the remote interface 3604 may command the infusion pump3602 including, but not limited to, commands related to: changes intherapy and various therapy commands including: setting related totherapy which may include but are not limited to, insulin sensitivityfactor, carbohydrate to insulin rations, blood glucose correctionfactors, blood glucose targets; delivery commands including boluscommands including normal and dual wave or extended bolus or combinationbolus; and setting basal rates as well as changing basal rates andcommanding temporary basal rates; alarms & alerts; log/history;initiation commands; setup/system edit; alarm and alert troubleshooting;reminders; reservoir changes and cannula changes etc., may all beentered by a user or caregiver through the remote interface 3604, andthese commands may be communicated to the infusion pump 3602. Althoughthis embodiment is shown to use a BTLE protocol, in various otherembodiments, any one or more wireless communication protocols may beused, including, but not limited to: BLUETOOTH/BLUETOOTH Low Energy orother non-proprietary protocols and/or may include, but is not limitedto, one or more of the following protocols: WiFi, ZIGBEE, XB, WiFi adhoc, White Space, Ultra wide band, Ant, and/or wireless USB. In someembodiments, the communication may be the same between each device, andin some embodiments, the communications may differ between each device.Additionally, the devices, in some embodiments, may communicate viawired and/or USB connection. In any one or more of the embodimentsdescribed above, in some embodiments, the one or more devices mayinclude two or more radios with the ability to communicate by way ofBLUETOOTH Low Energy and/or BLUETOOTH High Energy and/or by way of a lowenergy protocol and a high energy protocol. For example, in someembodiments, the remote interface 3604 may communicate using a low powerprotocol radio with the infusion pump 3602 and a high energy BLUETOOTHradio or high power protocol radio with the blood glucose meter 3608.

Referring now also to FIG. 37 one embodiment of the various embodimentsof the system is shown. In this embodiment, the system 3600 includes aninfusion pump 3602 a mini-remote interface 3610, a continuous glucosemonitor/transmitter 3606 and a blood glucose meter 3608. In thisembodiment, the various devices 3602, 3606, 3608, 3610 may communicateusing a BLUETOOTH Low Energy (BTLE) protocol. However, this embodimentof the system 3600 additionally includes a personal computer 3612 thatmay be connected to the mini-remote interface 3610, when desired, via aUSB/wired connection. Also, in this embodiment, the infusion pump 3602and the mini-remote interface 3610 communicate using two waycommunications. In this embodiment, the mini-remote interface 3604 maycommand the infusion pump 3602 including all of the various commands anyembodiment of the remote interface 3604 (described above) may includewhich may include, but are not limited to, commands related to: changesin therapy and various therapy commands including: setting related totherapy which may include but are not limited to, insulin sensitivityfactor, carbohydrate to insulin rations, blood glucose correctionfactors, blood glucose targets; delivery commands including boluscommands including normal and dual wave or extended bolus or combinationbolus; and setting basal rates as well as changing basal rates andcommanding temporary basal rates; alarms & alerts; log/history;initiation commands; setup/system edit; alarm and alert troubleshooting;reminders; reservoir changes and cannula changes etc., may all beentered by a user or caregiver through the mini-remote interface 3610,and these commands may be communicated to the infusion pump 3602.Additionally, the personal computer 3612 may communicate via USB withthe mini-remote interface 3610 and in some embodiments, thiscommunication may be limited to various predefined/preselectedfunctions. For example, in some embodiments, the personal computer 3612may be used to modify or establish a basal profile and/or viewlog/history. This may be desirable for many reasons, including but notlimited to, the ability to attach the mini-remote interface 3610 to anypersonal computer desired 3612 and log into, for example, a web site,which in some embodiments may be secure/password protected, and modifyone or more of the basal profile and/or view log/history, which may bedesirable for many reasons, including, but not limited to, a physicianor medical provider viewing logs/history as well as basal profiles andmodifying same. In some embodiments, additional functions may be viewedand/or modified using the personal computer 3612. In some embodiments,the functions that may be viewed and/or modified may vary and/or bepreset and/or predefined and/or hardwired into the system. In someembodiments, the personal computer 3612 may be used to view/modify moreor less functions including, but not limited to, any one or more of thefollowing: settings and/or setup, as well as food libraries andpreferences for alerts including but not limited to reminders.

Although this embodiment is shown to use a BTLE protocol and a USBconnection, in various other embodiments, any one or more wirelesscommunication protocols may be used, including, but not limited to:BLUETOOTH/BLUETOOTH Low Energy or other non-proprietary protocols and/ormay include, but is not limited to, one or more of the followingprotocols: WiFi, ZIGBEE, XB, WiFi ad hoc, White Space, Ultra wide band,Ant, and/or wireless USB. In some embodiments, the communication may bethe same between each device, and in some embodiments, thecommunications may differ between each device. Additionally, two or moreof the devices, in some embodiments, may communicate via wired and/orUSB connection and/or may communicate with a particular device via wiredand/or USB connection but may communicate with other devices viawireless communication. In any one or more of the embodiments describedabove, in some embodiments, the one or more devices may include two ormore radios with the ability to communicate by way of BLUETOOTH LowEnergy and/or BLUETOOTH High Energy and/or by way of a low energyprotocol and a high energy protocol. For example, in some embodiments,the remote interface 3604 may communicate using a low power protocolradio with the infusion pump 3602 and a high energy BLUETOOTH radio orhigh power protocol radio with the blood glucose meter 3608.

Referring now also to FIG. 38 one embodiment of the various embodimentsof the system is shown. In this embodiment, the system 3600 includes aninfusion pump 3602, a remote interface 3604, a mini-remote interface3610, a continuous glucose monitor/transmitter 3606 and a blood glucosemeter 3608. In this embodiment, the various devices 3602, 3604, 3606,3608, 3610 may communicate using a BLUETOOTH Low Energy (BTLE) protocol.However, this embodiment of the system 3600 additionally includes apersonal computer 3612 that may be connected to the mini-remoteinterface 3610, when desired, via a USB/wired connection. Also, in thisembodiment, the infusion pump 3602 and the mini-remote interface 3610communicate using two way communications. In this embodiment, themini-remote interface 3604 may command the infusion pump 3602 includingall of the various commands any embodiment of the remote interface 3604and/or the mini-remote interface 3610 (described above) may includewhich may include, but are not limited to, commands related to: changesin therapy and various therapy commands including: setting related totherapy which may include but are not limited to, insulin sensitivityfactor, carbohydrate to insulin rations, blood glucose correctionfactors, blood glucose targets; delivery commands including boluscommands including normal and dual wave or extended bolus or combinationbolus; and setting basal rates as well as changing basal rates andcommanding temporary basal rates; alarms & alerts; log/history;initiation commands; setup/system edit; alarm and alert troubleshooting;reminders; reservoir changes and cannula changes etc., may all beentered by a user or caregiver through the mini-remote interface 3610,and these commands may be communicated to the infusion pump 3602.Additionally, the personal computer 3612 may communicate via USB withthe mini-remote interface 3610 and in some embodiments, thiscommunication may be limited to various predefined/preselectedfunctions. For example, in some embodiments, the personal computer 3612may be used to modify or establish a basal profile and/or viewlog/history. This may be desirable for many reasons, including but notlimited to, the ability to attach the mini-remote interface 3610 to anypersonal computer desired 3612 and log into, for example, a web site,which in some embodiments may be secure/password protected, and modifyone or more of the basal profile and/or view log/history, which may bedesirable for many reasons, including, but not limited to, a physicianor medical provider viewing logs/history as well as basal profiles andmodifying same. In some embodiments, additional functions may be viewedand/or modified using the personal computer 3612. In some embodiments,the functions that may be viewed and/or modified may vary and/or bepreset and/or predefined and/or hardwired into the system. In someembodiments, the personal computer 3612 may be used to view/modify moreor less functions including, but not limited to, any one or more of thefollowing: settings and/or setup, as well as food libraries andpreferences for alerts including but not limited to reminders.

In some embodiments of this embodiment of the system 3600, the remoteinterface 3604 may serve as a larger display for the mini-remoteinterface 3610, however, may not be used to command the infusion pump3602 or command the mini-user interface 3610. For example, in someembodiments, the remote interface 3604 may be used to display dataincluding logs and/or history and/or CGM and/or BG meter trending and/orgraphs and/history. Thus, in some embodiments, the remote interface 3604may be desirable as a larger display (and portable larger display) todisplay data and other information larger and/or more clearly for theuser/caregiver. In various embodiments of this embodiment, the remoteinterface 3604 may be any type of interface including, but not limitedto, a smart phone and may include a downloadable application. Thus, insome embodiments the remote interface 3604 may be an MDDS or MedicalDevice Data Systems and the mini-remote interface 3610 may be aproprietary device including secure protocols.

Although this embodiment is shown to use a BTLE protocol and a USBconnection, in various other embodiments, any one or more wirelesscommunication protocols may be used, including, but not limited to:BLUETOOTH/BLUETOOTH Low Energy or other non-proprietary protocols and/ormay include, but is not limited to, one or more of the followingprotocols: WiFi, ZIGBEE, XB, WiFi ad hoc, White Space, Ultra wide band,Ant, and/or wireless USB. In some embodiments, the communication may bethe same between each device, and in some embodiments, thecommunications may differ between each device. Additionally, two or moreof the devices, in some embodiments, may communicate via wired and/orUSB connection and/or may communicate with a particular device via wiredand/or USB connection but may communicate with other devices viawireless communication. In any one or more of the embodiments describedabove, in some embodiments, the one or more devices may include two ormore radios with the ability to communicate by way of BLUETOOTH LowEnergy and/or BLUETOOTH High Energy and/or by way of a low energyprotocol and a high energy protocol. For example, in some embodiments,the remote interface 3604 may communicate using a low power protocolradio with the infusion pump 3602 and a high energy BLUETOOTH radio orhigh power protocol radio with the blood glucose meter 3608.

Referring now also to FIG. 39 one embodiment of the various embodimentsof the system 3600 is shown. In this embodiment, the system 3600includes an infusion pump 3602, a remote interface 3604, a mini-remoteinterface 3610, a continuous glucose monitor/transmitter 3606 and ablood glucose meter 3608. In this embodiment, the various devices 3602,3604, 3606, 3608, 3610 may communicate using a BLUETOOTH Low Energy(BTLE) protocol. However, this embodiment of the system 3600additionally includes a personal computer 3612 that may be connected tothe mini-remote interface 3610, when desired, via a USB/wiredconnection. Also, in this embodiment, the infusion pump 3602 and themini-remote interface 3610 communicate using two way communications andthe mini-remote interface 3610 and the remote interface 3604 maycommunicate using two way communications.

In one embodiment of this embodiment, either the mini-remote interface3610 or the remote interface 3604 may command the infusion pump 3602including all of the various commands any embodiment of the remoteinterface 3604 or mini-remote interface 3610 (described above) mayinclude which may include, but are not limited to, commands related to:changes in therapy and various therapy commands including: settingsrelated to therapy which may include but are not limited to, insulinsensitivity factor, carbohydrate to insulin rations, blood glucosecorrection factors, blood glucose targets; delivery commands includingbolus commands including normal and dual wave or extended bolus orcombination bolus; and setting basal rates as well as changing basalrates and commanding temporary basal rates; alarms & alerts;log/history; initiation commands; setup/system edit; alarm and alerttroubleshooting; reminders; reservoir changes and cannula changes etc.,may all be entered by a user or caregiver through the mini-remoteinterface 3610, and these commands may be communicated to the infusionpump 3602. Additionally, the personal computer 3612 may communicate viaUSB with the mini-remote interface 3610 and in some embodiments, thiscommunication may be limited to various predefined/preselectedfunctions. For example, in some embodiments, the personal computer 3612may be used to modify or establish a basal profile and/or viewlog/history. This may be desirable for many reasons, including but notlimited to, the ability to attach the mini-remote interface 3610 to anypersonal computer desired 3612 and log into, for example, a web site,which in some embodiments may be secure/password protected, and modifyone or more of the basal profile and/or view log/history, which may bedesirable for many reasons, including, but not limited to, a physicianor medical provider viewing logs/history as well as basal profiles andmodifying same. In some embodiments, additional functions may be viewedand/or modified using the personal computer 3612. In some embodiments,the functions that may be viewed and/or modified may vary and/or bepreset and/or predefined and/or hardwired into the system. In someembodiments, the personal computer 3612 may be used to view/modify moreor less functions including, but not limited to, any one or more of thefollowing: settings and/or setup, as well as food libraries andpreferences for alerts including but not limited to reminders.

In some embodiments of this embodiment the remote interface 3604 mayserve as a larger display version of the mini-remote interface 3610, andmay not be used to command the infusion pump 3602 or command themini-user interface 3610. Thus, in some embodiments, the remoteinterface 3604 may be desirable as a larger display (and portable largerdisplay) to display data and other information larger and/or moreclearly for the user/caregiver. In various embodiments of thisembodiment, the remote interface 3604 and the mini-remote interface 3610may each be any type a proprietary device including secure protocols.

Although this embodiment is shown to use a BTLE protocol and a USBconnection, in various other embodiments, any one or more wirelesscommunication protocols may be used, including, but not limited to:BLUETOOTH/BLUETOOTH Low Energy or other non-proprietary protocols and/ormay include, but is not limited to, one or more of the followingprotocols: WiFi, ZIGBEE, XB, WiFi ad hoc, White Space, Ultra wide band,Ant, and/or wireless USB. In some embodiments, the communication may bethe same between each device, and in some embodiments, thecommunications may differ between each device. Additionally, two or moreof the devices, in some embodiments, may communicate via wired and/orUSB connection and/or may communicate with a particular device via wiredand/or USB connection but may communicate with other devices viawireless communication. In any one or more of the embodiments describedabove, in some embodiments, the one or more devices may include two ormore radios with the ability to communicate by way of BLUETOOTH LowEnergy and/or BLUETOOTH High Energy and/or by way of a low energyprotocol and a high energy protocol. For example, in some embodiments,the remote interface 3604 may communicate using a low power protocolradio with the infusion pump 3602 and a high energy BLUETOOTH radio orhigh power protocol radio with the blood glucose meter 3608.

Still referring to FIG. 39 , in this embodiment, the system 3600includes an infusion pump 3602, a remote interface 3604, a mini-remoteinterface 3610, a continuous glucose monitor/transmitter 3606 and ablood glucose meter 3608. In this embodiment, the various devices 3602,3604, 3606, 3608, 3610 may communicate using a BLUETOOTH Low Energy(BTLE) protocol. However, this embodiment of the system 3600additionally includes a personal computer 3612 that may be connected tothe mini-remote interface 3610, when desired, via a USB/wiredconnection. Also, in this embodiment, the infusion pump 3602 and themini-remote interface 3610 communicate using two way communications andthe mini-remote interface 3610 and the remote interface 3604 maycommunicate using two way communications.

In another embodiment of the embodiment shown in FIG. 39 , themini-remote interface 3610 and the remote interface 3604 togetherfunction collectively as a single remote interface or mini-remote userinterface as described above. In some embodiments, the remote interface3604 may perform non safety critical steps/functions and may be anydevice, including a smart phone, and may include a downloadableapplication. Thus, in some embodiments the remote interface 3604 may bean MDDS or Medical Device Data System. In these embodiments, themini-remote interface 3610 may be a proprietary device including secureprotocols and may perform safety critical steps/functions.

Thus, in these embodiments, the mini-remote interface 3610 may commandthe infusion pump 3602 and the remote interface 3604 and the mini-remoteinterface 3610 may communicate with each other. However, in someembodiments, the critical steps/commands/confirmations are only inputthrough the mini-remote interface 3610. Referring now also to FIG. 40 ,an example of a method for commanding the delivery of a bolus 4000 isshown. This method is one embodiment and shows the steps of commanding anormal bolus, however, similar steps may be used to command any type ofbolus. The user/caregiver first enters the number of units requested forthe bolus using the remote interface (3604) 4002 (and in someembodiments, the blood glucose and the carbohydrates may also be enteredinto the remote interface 3604 using the bolus calculator). The remoteinterface 3604 displays an instruction to the user/caregiver to confirmthe bolus amount using the mini-remote interface (3610) 4004 (thus, theremote interface 3604 in various embodiments either displays the numberof units entered by the user/caregiver or, in a bolus calculatorfunction, shows the number of units recommended based on the input bloodglucose value and carbohydrates). The user/caregiver then must confirmthe bolus amount displayed using the mini-remote interface (3610) 4006.In various embodiments, the mini-remote interface may include a messagethat shows the user the number of units the bolus will deliver, e.g.,4.0 units, and may include a go, start or confirm icon and also a cancelicon, which, in some embodiments, the cancel icon may be highlighted asa default. In some embodiments, using the remote interface 3604, theuser may modify the number of units either in the normal bolus or thenumber resulting from the calculation in a bolus calculator function.However, the user/caregiver then confirms the amount on the mini-remoteinterface (3610) 4006 and the mini-remote interface (3610) commands theinfusion pump to deliver the bolus 4008. The infusion pump 3602 thendelivers the bolus 4010. In various embodiments, the user may select tocancel the bolus using the mini-remote interface rather than confirm theamount in step 4006. Also, in various embodiments, the delivery of thebolus in step 4010 may be cancelled by a user/caregiver cancelling thebolus delivery using the mini-remote interface 3610. Thus, in theseembodiments, safety critical commands are only sent from the mini-userinterface 3610. The remote interface 3604 is used to input informationand view information, thus presenting to the user/caregiver a larger andin some embodiments, clearer display, which may be beneficial for manyreasons, including but not limited to, the ability to present largeamounts of information on the display at any given time, the ability topresent information in a larger format, the ability to navigate tovarious menu items easily and quickly. Whereas the mini-remote interface3610 in some embodiments includes a limited screen and thus may be moredifficult for a user/caregiver to view large amounts of information on asingle screen. Thus, the embodiments described above present an MDDS todisplay non safety critical information and a proprietary secure,smaller device, to present safety critical information and to commandsafety critical information. In various embodiments of this embodiment,all safety critical inputs must be confirmed on the mini-remoteinterface 3610 before the commands are sent to the infusion pump 3602.For example, and referring now also to FIG. 41 , where theuser/caregiver uses the remote interface 3604 to enter or change safetycritical settings and or enter a command 4100, the remote interfacedisplays an instruction for the user/caregiver to confirm theentry/change to the safety critical settings and/or command on themini-remote interface 4102. A confirmation screen on the mini-remoteinterface 3610 then requests that the user confirm or cancel the settingor command 4104. If the user confirms the setting or command on themini-remote interface (3610) 4106, then the setting/command iscommunicated to the infusion pump 3602 and/or implemented into thesystem 4108.

In various embodiments, safety critical commands and/or settings mayinclude, but are not limited to, one or more of the following: anysetting or command that effects either the computation of the amount ofinfusible fluid (e.g., insulin) to deliver to the user, the amount ofinfusible fluid (e.g., insulin) to deliver to the user, the time ofdelivery of the infusible fluid to the user, and/or commands thedelivery of infusible fluid to the user; and/or the cancelling ofdelivery of infusible fluid. In some embodiments, therefore, the remoteinterface 3604 may be used for non safety critical inputs and viewing,for example, initiate commands (but not confirming them), enteringinformation for the bolus calculator/wizard and viewing the calculationsand recommended volume of infusible fluid to be delivered using theremote interface 3604, but not confirming the information/volume orinstructing the infusion pump 3602 to deliver. Also, the remoteinterface 3604 may be used to view alarms and alerts, to troubleshootalarms and alerts, to view logbook/logs and history, to set up and editbasal profiles. However, in some embodiments, while setting up andediting basal profiles may be completed using the remote interface 3604(or the person computer 3612), they must be confirmed using themini-remote interface 3610. In some embodiments, setting up and editingbasal profiles may be completed and confirmed using the remote interface3604 (or the person computer 3612). In addition, in various embodiments,reminders may be entered using the remote interface 3604 and in someembodiments, the reminders do not require a confirmation from themini-remote interface 3610, however, in some embodiments, the remindersdo require a confirmation from the mini-remote interface 3610. In someembodiments, settings such as time of day may require confirmation usingthe mini-remote interface 3610, however, in other embodiments, changesto the time of day may be done through the remote interface 3604.

In various embodiments, various changes and/or commands may beclassified as safety critical and require confirmation using themini-remote interface 3610, however, in some embodiments, variouschanges and/or command may be classified as non safety critical and maybe implemented through the remote interface 3604, and/or the personalcomputer 3612, depending on the embodiment. However, whicheverchanges/commands are classified as safety critical in any givenembodiment, these must be confirmed using the mini-remote interface 3610or may not be implemented/commanded to the infusion pump 3602. Thus, inthese embodiments, information that is sent from the remote interface3604 to the mini-remote interface 3610 is treated as data and is nottreated as a command and none of this data is communicated to theinfusion pump 3602 until and unless the user/caregiver confirms theinformation on the mini-remote interface 3610. Thus, in theseembodiments, the remote interface 3604 cannot command the infusion pump3610 directly.

Still referring to FIGS. 39-41 , in various embodiments,commands/settings that may be considered safety critical may include,but are not limited to, one or more of the following: commands relatedto: changes in therapy and various therapy commands including: settingsrelated to therapy which may include but are not limited to, insulinsensitivity factor, carbohydrate to insulin rations, blood glucosecorrection factors, blood glucose targets; delivery commands includingbolus commands including normal and dual wave or extended bolus orcombination bolus; and setting basal rates as well as changing basalrates and commanding temporary basal rates; confirming and/or silencingone or more alarms & alerts; initiation commands; setup/system edit;alarm and alert troubleshooting, may all be entered by a user orcaregiver through the remote interface 3604, but the final confirmationmust be completed on the mini-remote interface 3610 or thechanged/commands will not be communicated to the infusion pump 3602.Additionally, in some embodiments, the personal computer 3612 maycommunicate via USB with the mini-remote interface 3610 and in someembodiments, this communication may be limited to variouspredefined/preselected functions. For example, in some embodiments, thepersonal computer 3612 may be used to modify or establish a basalprofile and/or view log/history. This may be desirable for many reasons,including but not limited to, the ability to attach the mini-remoteinterface 3610 to any personal computer desired 3612 and log into, forexample, a web site, which in some embodiments may be secure/passwordprotected, and modify one or more of the basal profile and/or viewlog/history, which may be desirable for many reasons, including, but notlimited to, a physician or medical provider viewing logs/history as wellas basal profiles and modifying same. In some embodiments, additionalfunctions may be viewed and/or modified using the personal computer3612. However, in some embodiments, although the various functions maybe viewed and modified using the personal computer 3612, where thefunction is safety critical, the user/caregiver must confirm any changesusing the mini-remote interface 3610. In some embodiments, the functionsthat may be viewed and/or modified using the personal computer 3612 mayvary and/or be preset and/or predefined and/or hardwired into thesystem. In some embodiments, the personal computer 3612 may be used toview/modify more or less functions including, but not limited to, anyone or more of the following: settings and/or setup, as well as foodlibraries and preferences for alerts including but not limited toreminders.

In various embodiments, viewing and or changing log/history, alarms andalert troubleshooting, reminders including reservoir changes and cannulachanges etc., may not all be classified as non safety critical. In someembodiments, one or more of these may be classified as safety critical.

In some embodiments of this embodiment the remote interface 3604 mayserve as a larger display for the mini-remote interface 3610, however,may not be used to command the infusion pump 3602 or command themini-user interface 3610. For example, in some embodiments, the remoteinterface 3604 may be used to display data including logs and/or historyand/or CGM and/or BG meter trending and/or graphs and/history. Thus, insome embodiments, the remote interface 3604 may be desirable as a largerdisplay (and portable larger display) to display data and otherinformation larger and/or more clearly for the user/caregiver. Invarious embodiments of this embodiment, the remote interface 3604 may beany type of interface including, but not limited to, a smart phone andmay include a downloadable application. Thus, in some embodiments theremote interface 3604 may be an MDDS or Medical Device Data Systems andthe mini-remote interface 3610 may be a proprietary device includingsecure protocols.

Although this embodiment is shown to use a BTLE protocol and a USBconnection, in various other embodiments, any one or more wirelesscommunication protocols may be used, including, but not limited to:BLUETOOTH/BLUETOOTH Low Energy or other non-proprietary protocols and/ormay include, but is not limited to, one or more of the followingprotocols: WiFi, ZIGBEE, XB, WiFi ad hoc, White Space, Ultra wide band,Ant, and/or wireless USB. In some embodiments, the communication may bethe same between each device, and in some embodiments, thecommunications may differ between each device. Additionally, two or moreof the devices, in some embodiments, may communicate via wired and/orUSB connection and/or may communicate with a particular device via wiredand/or USB connection but may communicate with other devices viawireless communication. In any one or more of the embodiments describedabove, in some embodiments, the one or more devices may include two ormore radios with the ability to communicate by way of BLUETOOTH LowEnergy and/or BLUETOOTH High Energy and/or by way of a low energyprotocol and a high energy protocol. For example, in some embodiments,the remote interface 3604 may communicate using a low power protocolradio with the infusion pump 3602 and a high energy BLUETOOTH radio orhigh power protocol radio with the blood glucose meter 3608.

In some embodiments, to confirm a command on the mini-remote interface,the user may be required to swipe the screen either left to right, rightto left, top to bottom, bottom to top and/or diagonally. In someembodiments, one or more buttons will be required to be depressed for apredetermined, e.g. 3 second, period of time. However, in variousembodiments, the amount of time may be different. In some embodiments,the user may be required to place the mini-remote interface in closeproximity to the remote interface to confirm. In some embodiments,confirmation may be accomplished by depressing the switch assembly onthe infusion pump.

In some embodiments where the mini-remote interface is required forconfirming a command, if the user/caregiver loses access to themini-remote interface, the user may use a predetermined encryptedsignal, e.g., dial tones, voice recognition, played/spoken to themini-the infusion pump to confirm the command. In some embodiments,there may be a secure call-center and the user/caregiver may call andafter identifying themselves using either a pass code, patientconfidential information, etc., receive a confirmation tone that may bereceived by the infusion pump to complete the command from the remoteinterface.

Pairing the various devices may be accomplished using any of the methodsdescribed above or those known in the art such as BLUETOOTH pairing.However, in some embodiments, the various devices may be paired usingNear Field Communication. In some embodiments, the devices may be pairedusing a wired connection including, but not limited to, a USBconnection. In some embodiments, the methods for pairing the infusionpump with the mini-remote interface and/or the remote interface and orany one or more of the various devices of the system with any one ormore device may include maintaining the devices to be paired in closeproximity to one another and performing the pairing in an area whereadditional devices are unlikely to interfere, e.g., the user/caregiver'shome/office.

Referring now also to FIG. 42 , a flow chart diagram that illustrates amethodology 4200 for securely communicating between one or more devices,such as between a medical device and a user interface/remoteinterface/mini-user interface device in accordance with an embodiment ofthe present disclosure is shown. The method 4200 includes acts4204-4220. In Act 4204, the master device and slave device establishcommunications on a communications link. The communications link may beunsecure. In some embodiments, the communications link may usepublic-private key cryptography. In Act 4206, The master device (e.g., amedical UI/remote interface/mini-remote interface device) and slavedevice (e.g., a blood glucose meter, continuous glucose monitortransmitter, etc) agree on a prime number, p, and a base number, g,using the communications link. The agreement may occur using anencrypted communications link, over a wired link, or usingpublic-private key-pair cryptography. The base number, g, is a primitiveroot modulo of p. P and g may be publically known. In Act 4208, themaster device generates a random number, a, and computes u=g{circumflexover ( )}a(mod p). In Act 4210, the master device sends, a, and u to theslave device. In Act 4212, the slave device generates a random number,b, and computers v=g{circumflex over ( )}b(mod p) and communicates b andv-g{circumflex over ( )}b(mod p) to the master device.

In Act 4216, The master device computers a key, k, where k=v{circumflexover ( )}a=(g{circumflex over ( )}b){circumflex over ( )}a(mod p). InAct 4218, the slave device computers the key, k, where k=u{circumflexover ( )}b=(g{circumflex over ( )}a){circumflex over ( )}b(mod p). Thesymmetric keys were never communicated; they were internally generatedby a respective device. In Act 4220, the master device and the slavedevice use the shared, secret key, k, as a seed to a symmetricalencryption key. The secret key may be used as an index to a pseudorandomnumber index, in which case, the pseudorandom number index is the keyfor the symmetrical keys.

Referring now also to FIGS. 43A-43J, some embodiments of screen shots onthe mini-remote interface 3610 are shown. In various embodiments, themini-remote interface 3610 may include one or more user inputs which mayinclude, but are not limited to, one or more of the following: one ormore buttons, scroll wheel, touch screen. In some embodiments, thedisplay may include a touch screen where the user/caregiver confirms orselects a particular command by first scrolling to select thatparticular command (which may be done using any of the user inputs) andthen touching the screen at another particular location and swiping thescreen either left to right or right to left. In some embodiments, tounlock the screen, for example, as shown in FIG. 43A, the user/caregivermay be required to swipe the screen from left to right, whereas in someembodiments, for example, as shown in FIG. 43J, to select or confirm,the user/caregiver may be required to swipe the screen from right toleft. This may be desirable/beneficial for many reasons, including butnot limited to, preventing unintentional confirmation by requiring theuser to confirm by swiping in a different direction than the directionof unlocking. In various embodiments, the direction for each action maybe different. In some embodiments, the direction for unlocking may beright to left and the direction for confirming/selecting may be left toright. In some embodiments, swiping the confirmation direction on ascreen which does not have any selections will advance the screen toanother screen, which may be the next screen in the user interface.Referring now also to FIGS. 43C-43D, in some embodiments, themini-remote interface 3610 may include a display that includes a menuselection. The menu selection may be scrolled through by swiping thescreen or by another user input. The menu selection may then be selectedby the user/caregiver. Referring now also to FIGS. 43E-43G, in variousembodiments, one the user/caregiver has navigated to the bolus homescreen, the user/caregiver may elect the type of bolus to deliver, forexample, using the wizard/calculator, manual or another type(represented by preset). In some embodiments, scrolling through the menuitems may be accomplished by using the touch screen, touching at aparticular position and then swiping up or down from that position asthe various options are highlighted. Once the option desired ishighlighted, the user/caregiver may select that option by swiping rightto left, for example, or by using another user input, for example, oneor more buttons and/or a scrollwheel. Referring now also to FIG. 43G,once the desired option is selected, e.g., Wizard, the user may swipethe screen. In some embodiments, the user may touch the screen toselect.

Referring now also to FIGS. 43K-43N, in various embodiments, once thebolus type, e.g., Wizard, is selected, the next screens request the userto enter the blood glucose value and the carbohydrate value. In variousembodiments, there may be a screen/scroll function for entering thesevalues and movement of the screen scroll may be effected by touch screenswiping the screen up or down to effect the scroll. In some embodiments,other user inputs may be used. In some embodiments, once the desiredvalues have been entered, the user may swipe the screen, e.g., right toleft, to select the values and move on to the next screen.

Referring also to FIGS. 43M and 43N, in various embodiments, themini-remote interface may include a timeout feature which may includethe display turning off or becoming locked after a predetermined amountof time, e.g., 3 seconds. In some embodiments, the mini-remote interfacemay give a warming to the user/caregiver of the timeout being close intime, for example, graying out part of the screen or fading out parts ofthe screen as shown in FIGS. 43M-43N. Other methods for warning of thetimeout may also be used.

Referring now also to FIG. 43O, in various embodiments, information maybe displayed to the user/caregiver on the display of the mini-remoteinterface and there may be displayed a symbol or word indicating eitheraccept or cancel. In various embodiments the user/caregiver may scrollto either the accept or cancel icon and select by either swiping in theappropriate direction or selecting using any one or more of the varioususer inputs.

In some embodiments, confirmation/selecting may be completed bypressing, for example, one or more or a combination of button userinputs simultaneously.

Various embodiments of screen shots and methods that may be used by theremote interface are discussed above. However, additional screen shotsand methods for the user interface, of which one or more may be used bythe mini-remote interface and/or the remote interface, in the variousembodiments of the systems described herein, are shown in FIGS. 44A-58T.

Referring now also to FIGS. 44A-44B, in various embodiments, the screenmay be locked which may be beneficial for many reasons, including, butnot limited to, prevention of unintentional changes in settings and/orcommands being sent to the infusion pump. In some embodiments, thelocked screen may require a passcode to unlock the screen. In variousembodiments, unless or until the passcode unlocks the screen, the screenremains locked and no settings may be changed nor commands sent.

Referring now to FIG. 45A, in various embodiments, the home screen mayinclude icons for selecting to navigate to a specific function menu.Referring now also to FIG. 45B, the icons may be seen located at thebottom of the home screen. In various embodiments, the home screen mayinclude information indicated the amount of insulin (or other infusiblefluid) remaining in the reservoir, the percentage of battery liferemaining and the current deliver rate(s) for basal and, whereapplicable, bolus. For example, in FIG. 45B, the home screen indicatesthat basal pattern A is currently delivering and the rate, e.g. 5.50Units/Hr, is also indicated. The home screen additionally indicates asquare wave bolus is saved and has delivered 1.02 of 1.88 units and thatthere are 6 minutes remaining in the square wave bolus.

Referring now also to FIG. 45C, the home screen shown includes anindication that a normal bolus is being delivered and that 10.04 of14.00 units has been delivered. During the bolus event, theuser/caregiver may stop the bolus by pressing the “stop bolus” button onthe home screen. Referring now also to FIGS. 45D and 45E, anotherembodiment of the home screen is shown. In FIG. 45D, a “basal override”event lasting 1 hour and 50 minutes is also indicated. In this example,the rate is indicated as 6.50 Units/Hr. Referring now also to FIG. 45E,in this embodiment of the home screen, a “Temp Basal Rate” event thatincludes a 50% increase of basal rate for 1 hour and 30 minutes isindicated. The rate is 6.25 Units/Hr. In both FIGS. 45D-45E, the activeinsulin is indicated, e.g. 0.21 Units. Thus, in all of the embodimentsshown, the home screen presents the current delivery status and theactive insulin/infusible fluid.

Referring now also to FIGS. 46A-46B, in various embodiments, a basalpattern may be programmed by entering the start and end times as well asthe rate for that time frame. In various embodiments, the basal patternmay be displayed as a graph representing the basal pattern deliveryrates throughout a twenty-four hour period. In various embodiments, asshown in FIG. 46B, once the basal pattern is programmed, theuser/caregiver may review the entire pattern, including the graphicalrepresentation, and the time frames on a single screen. In addition, thebasal pattern may be switched by selecting “switch basal patter” andthen selecting another basal pattern. The graphical representation maybe beneficial/desirable for many reasons, including, but not limited to,presenting the basal pattern/profile in a style which represents to theuser/caregiver easily and clearly when the rate is higher or lower andpresents a picture for the entire day.

Referring now also to FIGS. 47A-47C, in some embodiments, a basalpattern/profile may be programmed by the user/caregiver tracing therate, using the touch screen functionality of the interface and theirfinger or a stylus, etc. Once the basal pattern/profile is drawn, thesystem renders a graphical depiction and the user may view and/or editthe pattern/profile.

Referring now also to FIGS. 48A-48D, in various embodiments, to adjustany rate in a basal pattern, the user/caregiver may navigate to adjustthe basal pattern, then select the rate in which they wish to adjust.Once selected, an indication of the current rate, with scroll whenfunction, is presented to the user/caregiver. The user/caregiver maythen adjust the rate by using the arrows of the scroll wheel and thenselect “OK” to save the new rate.

Referring now also to FIGS. 49A-49B, in various embodiments, a temporarybasal rate may be set. In some embodiments this may be done bynavigating to the “set temporary rate” screen where the new rate may beentered (see FIG. 49B) using, in some embodiments, a keypad, and theduration of the new rate may be entered using, in some embodiments, ascroll wheel function (see FIG. 49A). The graphical depiction of thebasal pattern may also aid the user/caregiver in programming temporaryrates for they may visualize the difference between the rate before andafter the temporary rate which may aid in programming a sufficient rate.

Referring now also to FIGS. 50A-50B, in various embodiments, the basalpatterns/profiles may be managed using basal profile manager screens.For example, and as shown in FIG. 50A, in some embodiments, the basalpatterns may be viewed, collectively, on a single screen, whichindicated the number of units per day. This screen also includes thatcurrent pattern. This screen may also include a button to create a newpattern. In some embodiments, once a pattern is selected from the managebasal patterns screen, the graphical depiction of that pattern may beshown (see FIG. 50B) and options to adjust the rates, set as currentpattern, delete the pattern or copy the pattern (to create anotherpattern with a new name but having the same pattern).

Referring now to FIGS. 51A-51B, in various embodiments, the userinterface may include “preset bolus” options wherein the user/caregivermay preset bolus amounts and/or types of boluses for, e.g. breakfast,lunch and dinner. To request the delivery of the preset bolus, in someembodiments, the user selects a preset bolus, e.g. breakfast. Then theuser interface navigates to another screen (see FIG. 51B) that shows thebolus type and amount, e.g., normal bolus and 2.50 units. Theuser/caregiver may they select “deliver” and the preset bolus may bedelivered. In various embodiments, preset boluses may be added using thescreen shown on FIG. 51A, and/or adjusted, deleted or copied (see FIG.51B).

Referring now to FIGS. 52A-52D, in various embodiments, the userinterface may include a “bolus wizard” or bolus calculator. In variousembodiments, the bolus wizard or bolus calculator may request the userenter, using a keypad, the amount of carbohydrates and blood glucoseusing a keypad (the carbohydrate screen shot is shown in FIG. 52A. Theblood glucose keypad, in various embodiments, is similar). In someembodiments, however, the last blood glucose reading may be used if theuser elects to use it, or the user may elect to calculate the boluswithout using a blood glucose reading. The next screen, an embodimentsof which is shown in FIG. 52B, shows the user the calculations of thecorrection bolus, based on the blood glucose (which, in this example, is125 mg/dl), the insulin correction (based on the active insulin, which,in this example, is 2.45 units) and the meal bolus (based on thecarbohydrates). The total bolus amount is also shown (which, in thisexample, is 7.50). The user may then elect to adjust the calculated“total bolus” amount and/or deliver part or all of the total bolus as anextended bolus or “square wave” or “dual wave” bolus. Referring now toFIG. 52C, in various embodiments, to deliver a portion of the bolus as anormal bolus and a portion of the bolus as a square wave bolus (orextended bolus), the user interface presents to the user/caregiver asliding scale where the amount, represented in both units and percentageof the total, to be delivered as normal is represented on one side of aline and the amount, represented in both units and percentage of thetotal, to be delivered as a square wave on the other. The user/caregivermay adjust the percentage of the amount to be delivered as normal andsquare wave by moving the rectangular icon towards the square wave sideor normal size. While moving the rectangular icon, the totals on bothsides is adjusted such that the user/caregiver may watch the percentagesand total units change in real time.

Once the total amounts to be delivered as normal and square wave areselected, then the user/caregiver may program the duration of the squarewave using scroll wheels on the screen, see FIG. 52D.

Referring now also to FIG. 53 , in various embodiments, the presetboluses may also be adjusted to include normal and square wave portions.In various embodiments, the normal and square wave percentages arepre-programmed into the preset bolus. For example, in FIG. 53 , the“Lunch” preset bolus includes 1.25 units delivered as a normal bolus and1.25 units delivered as a square wave bolus over 1 hour, for a total of2.50 units.

In various embodiments, the user may enter a normal bolus amount andthen elect to deliver part or all of the total bolus as an extendedbolus or “square wave” or “dual wave” bolus. Referring now to FIG. 52C,in various embodiments, to deliver a portion of the bolus as a normalbolus and a portion of the bolus as a square wave bolus (or extendedbolus), the user interface presents to the user/caregiver a slidingscale where the amount, represented in both units and percentage of thetotal, to be delivered as normal is represented on one side of a lineand the amount, represented in both units and percentage of the total,to be delivered as a square wave on the other. The user/caregiver mayadjust the percentage of the amount to be delivered as normal and squarewave by moving the rectangular icon towards the square wave side ornormal size. While moving the rectangular icon, the totals on both sidesis adjusted such that the user/caregiver may watch the percentages andtotal units change in real time.

Referring now also to FIGS. 54A-54D, in various embodiments, variousreminders may be entered/programmed by the user/caregiver. Theseinclude, but are not limited to, a reminder for the user/caregiver tocheck blood glucose after bolus (see FIG. 54A). With respect to thecheck blood glucose reminder, the user/caregiver may program theduration between the bolus and the reminder by using a scroll wheel toprogram the hours and minutes until the reminder. Additionally, theuser/caregiver may turn the reminder on and off. Additional reminder mayinclude, but are not limited to, cannula fill blood glucose reminderwhich may be programmed to remind the user/caregiver to check theirblood glucose after a certain (programmed) duration after filling acannula. Also, an infusion site reminder may be programmed. As shown inFIG. 54D, in some embodiments, once the infusion site is changed, areminder may be set to remind the user/caregiver to change the infusionset again after a programmed number of days. The programmed number ofdays may be selected by the user/caregiver using a screen scroll wheel.In some embodiments, the system may include a default number of days,e.g. 2 days, which may be altered by the user/caregiver to any number ofdays desired, e.g., 3. As with other reminders, in this embodiments,this reminder may be turned on or off by the user/caregiver preference.In some embodiments, a reminder to check blood glucose may be set by theuser/caregiver and this may be set for any number of hours/minutes fromthe reminder creation time. In some embodiments, this type of reminderis triggered by the user/caregiver's desire, for example, in someembodiments; a user/caregiver may have recently treated a low bloodglucose with sugar and may desire a reminder to remind them to re-checktheir blood glucose after a certain duration of time, e.g., 15 minutes.However, any duration of time may be programmed by the user using, insome embodiments, and as shown in FIG. 54C, a screen scroll wheel.

Other reminders may be programmed by the user and include, but are notlimited to, a missed meal reminder. In some embodiments, theuser/caregiver may program a reminder for the times of day when a mealis expected. In some embodiments, if a bolus is not requested during apreprogrammed/user programmed duration before or after that time, areminder may alert the user that they may have either missed a meal orfailed to deliver a bolus for the meal. In various embodiments, thesereminders may be programmed to alert the user daily, as a recurrentreminder, or may be a single reminder.

Referring now also to FIG. 55A, in some embodiments, a walkaway alertmay be included in the remote interface/infusion pump/and/or mini-remoteinterface system. The user may turn the walkaway alert either on or offand may program the alert for a duration of time after the systemdetermines the controller and pump are out of range. In someembodiments, the duration may be preprogrammed and may be adjustable bythe user. In some embodiments, the user may adjust the duration using ascreen scroll wheel.

Referring now also to FIGS. 56A-56C, in some embodiments, the userinterface may include blood glucose targets which may be programmed bythe user/caregiver and which may be used in various calculations by thesystem, including, but not limited to, a blood glucose correction boluscalculation. In various embodiments, the user interface includes theability to set various blood glucose targets for various timeframes/intervals throughout a twenty-four hour period. In variousembodiments, the blood glucose targets may be represented to theuser/caregiver in a graphic form. The blood glucose targets, in variousembodiments, may include a low target and a high target for eachtimeframe/interval. This may be desirable for many reasons, including,but not limited to, the ability of the user/caregiver to visualize thevarious timeframes/intervals and the targets for that timeframe/interval in a single graphical representation. This may bebeneficial/desirable for many reasons, including but not limited to,selecting the correct targets when programming and in some embodiments,this may prevent errors in programming. In addition to the graphicalrepresentation, each timeframe/interval is written and includes the highand low targets (see FIG. 56A). To change a particular interval, theuser may, using the touchscreen, tap on the particular interval, and insome embodiments, may either tap on the written interval section or thegraphical representation of that interval. A new screen appears andincludes screen scroll wheels to change the intervals and/or change thetargets (low and/or high), see FIG. 56B. In some embodiments, byselecting the interval, the user may “delete target” by selecting theoption on the screen, see FIG. 56C.

Referring now to FIGS. 57A-57C in some embodiments, the user interfacemay include carbohydrate ratios which may be programmed by theuser/caregiver and which may be used in various calculations by thesystem, including, but not limited to, a meal bolus calculation and/or ameal and correction bolus calculation. In various embodiments, the userinterface includes the ability to set carbohydrate ratios for varioustime frames/intervals throughout a twenty-four hour period. In variousembodiments, the carbohydrate ratios may be represented to theuser/caregiver in a graphic form. The carbohydrate ratios, in variousembodiments, include value which represents the grams of carbohydratesper one unit of infusible fluid, e.g. insulin. This may be desirable formany reasons, including, but not limited to, the ability of theuser/caregiver to visualize the various timeframes/intervals and theratios for that time frame/interval in a single graphicalrepresentation. This may be beneficial/desirable for many reasons,including but not limited to, selecting the correct ratios whenprogramming and in some embodiments, this may prevent errors inprogramming. In addition to the graphical representation, eachtimeframe/interval is written and includes the carbohydrate ratio forthat timeframe/interval (see FIG. 57B). To change a particular interval,the user may, using the touchscreen, tap on the particular interval, andin some embodiments, may either tap on the written interval section orthe graphical representation of that interval. A new screen appears andincludes screen scroll wheels to change the intervals and/or change theratio, see FIG. 57C. In some embodiments, by selecting the interval, theuser may “delete target” by selecting the option on the screen, see FIG.57A.

Referring now to FIGS. 58A-58T, in various embodiments, the userinterface includes a logbook. In various embodiments, the logbookincludes both the functionality to receive information from auser/caregiver and process that information (termed “events”) as well asthe functionality to display the historical data of the system.Referring now to FIG. 58A, in some embodiments, the logbook home pagemay include the last blood glucose entered into the system (or, in someembodiments, collected directly by the system), the duration since thelast blood glucose, the volume of the last bolus delivery, as well asthe duration since the last bolus. The logbook home page, in someembodiments, also includes menu options for the user/caregiver tonavigate to various sections of the logbook. In some embodiments thevarious sections include, but are not limited to, “enter last glucose”,“enter event”, “view daily totals”, and “view event history”. In variousembodiments, the logbook home page additional includes menu icons tonavigate to another section of the user interface.

Referring now also to FIGS. 58B-58G, in some embodiments, the logbookincludes the ability for a user/caregiver to input an “event” which mayinclude the grams of carbohydrates ingested by the user, an exerciseevent, and/or an insulin injection/medicine event. The user/caregivermay then navigate to enter the appropriate event. In some embodiments,the user/caregiver may enter a “carb event” by navigating to theappropriate screen and entering the grams of carbohydrates consumed (seeFIG. 58B). In some embodiments, the user interface may also include thetype of carbohydrate/food consumed, for example, pizza, cupcake, sushi,lasagna, brown rice, mom's chicken soup, etc. Once the user/caregiverpresses “next”, the review screen appears (see FIG. 58C) which shows thegrams of carbohydrates as well as the time and date of the event. Insome embodiments, the user/caregiver may enter an “exercise event” bynavigating to the appropriate screen and entering the intensity of theexercise; whether low, medium, or high (see FIG. 58D). In someembodiments, the user interface may also include the type of exercise,whether skiing, hiking, walking, weight lifting, mountain biking,swimming, paddle boarding, kayaking, etc. Once the user/caregiverpresses “next”, the user/caregiver enters the duration of the exercise(see FIG. 58E). Finally, the details of the exercise event may bereviewed by the user/caregiver (see FIG. 58F). Once the user/caregiverconfirms the information is correct, the event is saved in the logbookfor future reference by the user/caregiver (see FIG. 58G). A similarevent entry method may be followed for entering an insulin injection orother medicine event. The type of medicine and the dosage may be enteredwhich will then be saved in the logbook and indicate the time as well asthe type and dosage for later review.

The ability to enter specific events may be beneficial/desirable formany reasons, including, but not limited to, the ability of theuser/caregiver to review previous events and track either the results ofthat event, for example, review blood glucose readings following theexercise, medicine or carb event, in order to make decisions withrespect to future dosages of insulin or other medicines, and/or makedecisions to change eating patterns based on results from exercise orfrom ingesting specific foods. The ease of entering these events mayencourage those with diabetes and other conditions to enter the eventswhich may lead to improved health.

Referring now also to FIGS. 58H-58L, in various embodiments, the logbookadditionally includes historical data which is presented to theuser/caregiver on request by navigating the user interface to the dailytotals (FIG. 58I), daily doses (FIG. 58J), total carbohydrates (FIG.58K) and average blood glucose (FIG. 58L) sections of the logbook.Referring also to FIG. 58H, the user/caregiver may select to view the“daily totals” from a specific date, e.g., Dec. 4, 2013. However, invarious embodiments, another date may be selected. The total daily dose,total carbs and average BG are then displayed for that particular date(FIG. 58I). The user/caregiver may then select to view in detail any oneof those menu items. Where the user/caregiver selects the “total dailydose” menu item, a daily dose screen appears (FIG. 58J) which in someembodiments includes the total insulin given, the percentages of basaland bolus with respect to the total, as well as the different types ofboluses delivers, e.g. carb (meal) bolus, BG (correction) bolus, manual(normal) bolus, etc. Where the user/caregiver selects the “total carbs”menu item, a total carbs screen appears (FIG. 58K) which in someembodiments includes the total carbohydrates (entered into the system,for example, in some embodiments, through carb/meal boluses,carbohydrate events and/or through bolus calculator with carbs entered),bolus wizard carbs (which includes carbs entered only through the boluswizard/bolus calculator with carbs entered), the time the carbs wereentered through the bolus wizard/bolus calculator, and the total logbookcarbs (carbs entered as an event) as well as the time of the carb event.In various embodiments, the types of information displayed on thevarious screens may vary.

Referring now also to FIG. 58L, in various embodiments, the logbookincludes an “average book glucose” screen which present informationregarding the blood glucose readings for a particular day (which isselected by the user/caregiver, and in this example, is Dec. 3, 2013).The average glucose screen includes the average blood glucose for allthe blood glucose readings that day and lists the number of readings bytime and any other comments/indications that the system or, in someembodiments, the user/caregiver, attributed to that reading (i.e.,through comments or preprogrammed target values). In some embodiments,the system may attribute the description of “LOW” to any blood glucosereading under the low blood glucose target for that timeframe/intervaland may attribute the description “HIGH” to any blood glucose readingabove the low blood glucose target for that timeframe/interval.

Referring now also to FIGS. 58M-58T, in various embodiments, auser/caregiver may view the events in the logbook, for example, byspecifying the date, e.g., Dec. 5, 2013 (see FIG. 58M). The eventhistory screen will present the various events from the specified date(FIG. 58N) which, in FIG. 58N is Dec. 4, 2013. For each event, auser/caregiver may select the event, for example, by tapping on thesection using the touchscreen, and the event itself will be shown. Forexample, if the first event shown in FIG. 58N, the “normal bolusstopped” event is selected, the screen shown in FIG. 58O will be shownwhich includes the specific information about the event. Likewise, if asetting changed event is listed in the event history, a user/caregivermay select the event, for example, by tapping on the section using thetouchscreen, and the event itself will be shown (see FIG. 58P). Thus,the user/caregiver may review exactly which settings were changes andwhen. If a dual wave bolus event is listed in the event history, auser/caregiver may select the event, for example, by tapping on thesection using the touchscreen, and the event itself will be shown (seeFIG. 58Q). The bolus event includes the type of bolus (dual wave) thetime of the event (7:14:22 pm) and the details, for example, the unitsdelivered as normal bolus and the units delivered as square wave bolus.If a basal rate change event is listed in the event history, auser/caregiver may select the event, for example, by tapping on thesection using the touchscreen, and the event itself will be shown (seeFIG. 58R). The basal rate change event includes the pattern changed andthe units of the pattern. If a temp basal event is listed in the eventhistory, a user/caregiver may select the event, for example, by tappingon the section using the touchscreen, and the event itself will be shown(see FIG. 58S). The temp basal event includes the percentage change ofthe basal, the time of the event and the duration. Referring now also toFIG. 58T, the logbook additionally includes a listing of all alarms andalerts. A user/caregiver may select the event, for example, by tappingon the section using the touchscreen, and the event itself will beshown. The various alarms and alerts include, but are not limited to:low insulin alert, inactivity alarm, walkaway alert, insulin temperaturealert, pump audio, and occlusion sensitivity. However, more or lessalarms and alerts may be included in various embodiments. When viewingthe alarm and alert, the screen displays the type of alarm or alert, thetime and in some embodiments, whether it was silenced.

As discussed above, in various embodiments of the infusion pumpembodiment, the system may include two or more reusable portions. Inthese cases, in some embodiments, while one reusable portion is in use,the other may be on a recharger. While the first reusable portion is inuse, as described above, therapy may be administered by the supervisorprocessor and the command processor. Actions by the reusable portion arecommunicated to the remote interface. To “switch” the reusable portions(such that the reusable portion on the charger becomes the reusableportion in use and vice versa), the controller, which has uploadedinformation during use from the first reusable portion, downloads thevarious logs onto the second reusable portion such that the memory onthe second reusable portion includes all of the same memory as the firstreusable portion. This is done during the pairing process. In one stepof the process, following pump activation (done, in some embodiments, bythe user holding down the switch assembly on the reusable portion whilethe remote interface is in connection mode). During this step, profilesand user therapy configurations are transferred to the second reusablepump and/or synchronized with the reusable portions nonvolatile memory.

One this step is completed, in some embodiments, the second reusableportion, after internalizing, sends the basal profile back to the remoteinterface, such that the remote interface verifies that the basalprofile is correct. This step may confirm that the second reusableportion receives that correct information. In some embodiments, thedisplay may show the user the basal profile and the user may confirm.

Thus, as described above with respect to administering therapy, theinfusion pump completes all decision making and controls the delivery ofinfusible fluid. The remote interface is an interface to the infusionpump and in some embodiments provides for an enhanced user interface(e.g. a display screen) with diverse opportunities to interact with thedevice (e.g., the infusion pump) and/or the user.

Information related to therapy is therefore stored on both thecontroller and in the reusable portion/infusion pumps nonvolatilememory. Thus during the connection process between the reusable portionand the remote interface, the remote interface may confirm that thereusable portion contains the updated information. If the remoteinterface determines that the reusable portion does not contain theupdated information, the remote interface updates the information and/orsynchronizes the reusable portion's nonvolatile memory with the updatesthat information. Thus, in various embodiments, all therapy informationand or profiles may be stored on both the reusable portions of theinfusion pump and on the remote interface.

As discussed above, the device 800 (which, in some embodiments, is aninfusion pump) may be configured to deliver an infusible fluid to auser. Further, the infusion pump 800 may deliver the infusible fluid byway of infusion events which may include sequential and/or multi-part,and/or discrete infusion events and/or one-time infusion events. Some ofthe infusion events may include, but not limited to, one or more of thefollowing: bolus, extended bolus, basal, temporary basal, combinationbolus. As is known in the art, a basal infusion event refers to therepeated infusion of small quantities of infusible fluid at a predefinedinterval (e.g. every three minutes) that may be repeated until stopped,e.g., by a user or by the system. Further, the basal infusion rates maybe pre-programmed and may include specified rates for pre-programmedtime-frames, e.g., a rate of 0.50 units per hour from 6:00 am-3:00 pm; arate of 0.40 units per hour from 3:00 pm-10:00 pm; and a rate of 1.0units per hour from 10:00 pm-6:00 am, and/or may include pre-programmedtime frame, e.g., 0.50 units for 1 hour then 1.0 for 2 hours, then 0.05units for 30 minutes. In some embodiments, the basal rate maypre-programmed to remain constant, for example, 1.0 units per hour, andmay not change throughout a time-frame. The basal rates may be repeatedregularly/daily and/or on particular days until otherwise changed. Thesepre-programmed basal rates may be referred to as a basal profile.

A temporary basal rate refers to the modification of an existing basalprofile/basal rate for a pre-defined time-frame. For example, where anexisting basal profile includes a rate of 2.0 units from 6 am-10 am, atemporary basal rate may be requested that modifies the 2.0 units rateby a percentage, by either increasing or decreasing the 2.0 units rateby that percentage, for example, decreasing the rate by 20%, over apre-defined period of time, for example, 30 minutes. In some instances,a temporary basal may include of modification of 100%, either higher orlower, than the basal profile rate and therefore, in some instances, thetemporary basal rate may be 0.00 units per hour for a pre-defined timeperiod.

As is known in the art, a bolus is a pre-determined volume of fluidwhich, when delivered as a normal bolus, is typically delivered as fastas the device can deliver the fluid. In some embodiments, bolus volumesof a pre-determined volume, e.g., 20 units, or larger may be deliveredat a slower than “normal bolus” rate, which may be desired by a user,for purposes of, for example, absorption into the tissue. However, inany case, typically bolus events are delivered over a short period oftime, for example, in some embodiments, in ten minutes or less.

Further and as is known in the art, an extended-bolus infusion event mayrefer to a pre-defined volume of fluid delivered in repeated injectionsof small quantities of infusible fluid at a predefined interval (e.g.every three minutes) over a pre-defined period of time (e.g., threehours). Some extended-bolus infusion events may include a pre-definedvolume of infusible fluid delivered as a normal bolus (i.e., apercentage of the total extended-bolus volume delivered as a normalbolus) followed by the remaining volume of the pre-defined volumedelivered as an extended-bolus infusion event (i.e., over a pre-definedperiod of time).

An extended-bolus infusion event may occur simultaneously with a basalinfusion event. In various embodiments, the control of the delivery ofvarious types of infusion events simultaneously may be as described inU.S. patent application Ser. No. 12/837,193, filed Jul. 15, 2010 andentitled Apparatus, Systems and Methods for An Infusion Pump Assembly,now U.S. Publication No. US-2011-0144574, published Jun. 16, 2011, whichis hereby incorporated herein by reference in its entirety.

Various embodiments of the infusion pump shown and described herein andalso various embodiments of infusion pumps, may include those apparatus,methods, devices and systems similar to or described in, but not limitedto, one or more of the following, including: U.S. Pat. No. 7,498,563,issued Mar. 3, 2009 and entitled Optical Displacement Sensor forInfusion Devices; U.S. Pat. No. 7,306,578, issued Dec. 11, 2007 andentitled Loading Mechanism for Infusion Pump; PCT Application Serial No.PCT/US2009/060158, filed Oct. 9, 2009 and entitled Infusion PumpAssembly, now Publication No. WO 2010/042814, published Apr. 15, 2010;U.S. patent application Ser. No. 13/076,067, filed Mar. 30, 2011 andentitled Infusion Pump Methods, Systems and Apparatus, now U.S.Publication No. US-2011-0230837, published Sep. 22, 2011; U.S. patentapplication Ser. No. 13/121,822, filed Mar. 30, 2011 and entitledInfusion Pump Assembly, now U.S. Publication No. US-2011-0208123,published Aug. 25, 2011; U.S. patent application Ser. No. 11/704,899,filed Feb. 9, 2007 and entitled Fluid Delivery Systems and Methods, nowU.S. Publication No. US-2007-0228071-A1 published Oct. 4, 2007; U.S.patent application Ser. No. 12/347,985, filed Dec. 31, 2008 and entitledInfusion Pump Assembly, now U.S. Publication No. US-2009-0299277-A1published Dec. 3, 2009; U.S. patent application Ser. No. 12/560,106filed Sep. 15, 2009 and entitled Systems and Methods for Fluid Delivery,now U.S. Publication No. US-2010-0185142-A1, published Jul. 22, 2010;U.S. patent application Ser. No. 12/837,193, filed Jul. 15, 2010 andentitled Apparatus, Systems and Methods for An Infusion Pump Assembly,now U.S. Publication No. US-2011-0144574, published Jun. 16, 2011; andU.S. patent application Ser. No. 13/011,384, filed Jan. 21, 2011 andentitled Method and System for Shape-Memory Alloy Wire Control, now U.S.Publication No. US-2011-0300001, published Dec. 8, 2011, all in whichare hereby incorporated herein by reference in their entireties, as wellas in various embodiments of various devices, a remote interface may beused. In some embodiments, the remote interface may be a proprietarydevice or a non-proprietary device and may include those described abovewith respect to FIGS. 6-8 . However, in some embodiments, the remoteinterface may be a multifunctional web connected/web enabled device, forexample, a GOOGLE ANDROID type device or any other device which may runusing an open source operating system, for example, the ANDROIDOperating System, which may include, but is not limited to a DROIDRAZER, by Motorola, Inc., Schaumburg, Ill., U.S.A.; an HTC GOOGLE Nexusone by HTC, Taoyuan 330, Taiwan; a SAMSUNG Nexus S by SAMSUNGCorporation; and a CASIO G'zOne Commando by CASIO COMPUTER CO., LTD.,Tokyo, Japan. In some embodiments, the remote interface may be a tabletor other personal computing device and/or in some embodiments, theremote interface may be any so-called “smart-phone” type device. Thus,in various embodiments, the remote interface may include peripheralsincluding but not limited to: GPS, accelerometer, phone, web connection,camera, email, etc.

Referring now also to FIG. 18 and FIG. 19 , in some embodiments, theremote interface 1800, 1900 may be, or have the ability of, a webconnected remote interface which may include, but is not limited to,capability to download applications, download software updates, uploadinformation and/or send information to various machines, including, butnot limited to, through a web based secure portal and/or throughelectronic mail and/or by way of a wireless communications protocol.Thus, in various embodiments, the remote interface application may runon any capable device and is not limited to a so-called proprietarydevice. Further, in some embodiments, the remote interface may beBLUETOOTH® enabled, or otherwise enabled, to communicate, for example,using radio frequency (“RF”) communication, with one or more deviceswhich may include, but are not limited to, one or more of the following:an infusion pump 1802, 1902 and/or a continuous glucose monitortransmitter/sensor 1804, 1904 (“CGM”) and/or a BLUETOOTH® or othercommunication protocol enabled blood glucose meter 1806, 1906 and/or anyother medical device and/or patient care device or any other device.

Although FIGS. 18-19 illustrates the remote interface 1800, 1900 beingin communication with a personal computer 1808, 1908, infusion pump1802, 1902, blood glucose meter 1806, 1906 and/or CGM 1804, 1904, invarious embodiments, the remote interface 1800, 1900 may be incommunication with one or more of any one of a personal computer 1808,1908 (which, in some embodiments, may be a web portal), infusion pump1802, 1902, blood glucose meter 1806, 1906 and/or CGM 1804, 1904, and/orany one or more of any other device including, but not limited to,medical device. Further, in some embodiments, one or more of thepersonal computer 1808, 1908 (which, in some embodiments, may be a webportal), infusion pump 1802, 1902, blood glucose meter 1806, 1906 and/orCGM 1804, 1904, may in addition to being in communication with theremote interface 1800, 1900, may also be in communication with one ormore of the following: a personal computer 1808, 1908 (which, in someembodiments, may be a web portal), an infusion pump 1802, 1902, a bloodglucose meter 1806, 1906 and/or a CGM 1804, 1904. In some embodiments,the remote interface 1800, 1900 may be in communication with one or moredevices not described herein, however, it should be appreciated that theremote interface 1800, 1900 may be in communication with any device.Further, communication may be defined as one-way and/or two-waycommunication. In some embodiments, the web portal may be a secure webportal.

In some embodiments, the remote interface device 1800, 1900 may sharedata to a secure web page/web portal/personal computer 1808, 1909. Thisshared data may, in some embodiments, be automatically transferred 1810,1910 at predetermined and/or preprogrammed intervals (i.e.,synchronized). In some embodiments, data from the remote interface 1800,1900 is uploaded to the secure web page/web portal/personal computer1808, 1908 by a password protected application which, in someembodiments, ensures the information is not shared. In some embodiments,the information from the remote interface 1800, 1900 may be stored on asecured web page and thus, the information may be downloaded to areplacement remote interface and/or a second remote interface and/orother devices upon request. Thus, in some embodiments, this systemallows for a remote interface 1808, 1908 to be easily replaced uponmalfunction and/or loss. As discussed above, in some embodiments, thesecure web page and/or the transfer of data is secured by a password orother type of security.

Further, a secure web portal/personal computer 1808, 1908 may beutilized by a user to review infusion pump therapy, CGM data and/orglucose meter data (as well as, in some embodiments, additional devicesconnected either to the remote interface 1800, 1900 and/or to the secureweb page/personal computer 1808, 1908 in the same location. Further, thesecure web page/personal computer 1808, 1908 may include a food libraryand/or user customizable therapy recommendations that may be customizedby the user on, for example, a personal computer and then, in someembodiments, automatically synchronized with the remote interface 1800,1900. In some embodiments, the user may edit and/or “tag” the CGM and/orinfusion pump and/or other data with an event. These edits may beentered in real time, i.e., while the event is occurring, or at a latertime. These events, in some embodiments, may then be “named” by theuser, and, in some embodiments, therapy regimes may be preprogrammed bythe user for each of these events. For example, if a user is eatingpizza, the user may associate the therapy given with the food beingconsumed, which may include, but is not limited to, indication of numberof slices and the origin of the slices, e.g., “Sal's Pizza, cheese, 2slices”. Thus, the user may enter this into the remote interface 1800,1900 and, in some embodiments, later, while reviewing the CGM and/orpump and/or glucose meter data, the user may design a therapy to be usedwhen eating “Sals Pizza, cheese, 2 slices”. The user may name this eventand the therapy may be associated with this name. Thus, the user mayselect the “Sals Pizza, cheese, 2 slices” event at any time andauthorize the remote interface 1800, 1900 to institute the saved therapythat is associated with the pizza. In some embodiments, events may belinked to the food library, thus, as a user includes an item from thefood library, the remote interface 1800, 1900 may “link” the fooditem(s) with therapy and/or CGM and/or blood glucose meter data. Asdiscussed above, changes to software and/or profiles may be made by theuser using a personal computer (and/or a secure web page) 1808, 1908 andthese changes may be uploaded onto the remote interface 1800, 1900. Oncethese changes are uploaded from the personal computer (and/or a secureweb page) 1808, 1908 to the remote interface 1800, 1900, they may thenbe downloaded onto other devices connected to the remote interface 1800,1900, including, but not limited to, the infusion pump 1802, 1902.

In some embodiments, rather than a web page, there may be a dedicatedapplication on the remote interface 1800, 1900 including similarfunctionality as discussed above with respect to, for example, the foodlibrary and/or user customizable therapy recommendations, which may beperformed directly on the remote interface device. In some of theseembodiments, the dedicated application may be updated to the remoteinterface 1800, 1900 by downloading information from, e.g., web databasewhich, in some embodiments, may be a secure web database.

Thus, the user may perform post event analysis and design and/or makechanges to therapies based on analysis. In some embodiments, the usermay use this information and examine the trends and modify basal and/orbolus profiles. In some embodiments, the analysis may be completed withor by a physician and/or caregiver through the secure web page 1808,1908. In some embodiments, the user may “filter” the database forspecific events and/or foods consumed and analyze them with their caregiver or alone, to determine basal and/or bolus profiles to link withspecific events and/or food items. Thus, in some embodiments, the usermay, using the remote interface 1800, 1900 (or the secure web page 1808,1908) filter out all, e.g., “Sals Pizza, cheese, 2 slices”, events andanalyze both the therapy, the time of the event and the CGM profileand/or blood meter readings for that event.

In some embodiments, the remote interface 1800, 1900 may learn userhabits both from the collected CGM and/or pump and/or glucose meter datatogether with information entered by the user. Applications and/orsoftware may recommend therapy changes and those recommendations may beaccepted or denied by the user.

In some embodiments, the CGM and/or infusion pump and/or blood glucosemeter data and/or event data may be delivered to a secure web portal1808, 1908 set up between the user and the user's doctor and/or medicalprovider. In some embodiments, the secure web portal used by the user'sphysician and/or medical provider may be separate from the user's secureweb portal. Thus, in some embodiments, the portal may require the userto either accept, or deny, recommended changes, etc., prior to anychanges being downloaded and/or synchronized with the remote interface1800, 1900 from the secure web portal 1808, 1908 accessed by the user'sphysician and/or medical provider.

In some embodiments, the CGM sensor 1804, 1904 may communicate directlywith the infusion pump 1802, 1902 and/or the remote interface 1800, 1900(see FIGS. 18 and 19 ). In some embodiments, the CGM sensor 1804, 1904may communicate with one or the other and in some embodiments, the CGMsensor 1804, 1904 may communication with both the infusion pump 1802,1902 and the remote interface 1800, 1900. In some embodiments, safetycritical information, e.g., alarms, may be communicated directly to theinfusion pump 1802, 1902 and the remote interface 1800, 1900 may be usedmerely as a display.

Referring now also to FIG. 7 , in some embodiments, the remote interface1800, 1900 may include at least one accelerometer as well as at leastone screen containing multiple buttons 706, 710, which in someembodiments, may be customizable by the user. The buttons 706, 710, insome embodiments, may be used to directly navigate to a particularscreen, for example, but not limited to, in order to enter informationconcerning events and/or to simply indicate to the remote interface 524the event is occurring. In some embodiments, this information may bestored and sent to a secure web page and/or other which may include theability to synchronize with therapy/infusion pump information and/or CGMand/or blood glucose meter information.

In some embodiments, information may be sent to a remote interface 1800,1900 for a security monitoring service. The service may monitor and calland/or text (e.g., “are you OK?”) the remote interface 1800, 1900 whendata indicates there may be a problem, for example, a low blood glucoseis indicated and/or an infusion pump alert/alarm and/or a CGMalert/alarm has not been confirmed, e.g., an alarm/alert has not beenacknowledged/verified by the user which may include, but is not limitedto, a button press and/or screen touch to acknowledge receipt of thealarm/alert. For example, in some embodiments, where the user fails torespond to a service call and/or text, the service may then call anemergency service and/or a parent or guardian and/or emergency contact.In some embodiments, a GPS in the remote interface 1800, 1900 may locatethe user and thus, emergency personal may be contracted and called tothe user. In some embodiments, where the service has contacted a parentor emergency personal or emergency contact, the service may also sendthe current CGM and/or pump data for review.

As discussed above, in some embodiments, the remote interface 1800, 1900may be web enabled (and/or have access to a database which may be eitherdownloaded onto the remote interface 1800, 1900 or accessed by theremote interface 1800, 1900), and in some embodiments, the user mayaccess menus and/or nutritional information easily using the remoteinterface 1800, 1900. In some embodiments, this information may be “autofilled” into a bolus calculator and/or other to assist in calculatingcarbohydrates, fat content, etc. and determining the proper therapy. Insome embodiments, the actual calculations may be performed on the device(which, in some embodiments, may be an infusion pump 1802, 1902) but theremote interface 1800, 1900 may be the user interface the user uses toinput information.

In some embodiments, the remote interface 1800, 1900, secure web page1808, 1908 and infusion pump 1802, 1902 may be encrypted with, in someembodiments, 128 bit encryption. However, in other embodiments, theencryption may vary.

In some embodiments, the remote interface 1800, 1900 may pair with thedevices, which may include an infusion pump 1802, 1902 and/or a CGMsensor 1802, 1902 532 and/or a blood glucose meter 1806, 1906, through aseries of audio indications, i.e., sounds. The sounds may bepersonalized and/or unique to each remote interface 1800, 1900 which mayincrease safety in pairing the remote interface 1800, 1900 to the user'sdevice(s). In some embodiments, pairing may be accomplished using NFC(near field communication), i.e., holding the device and remoteinterface 1800, 1900 close enough to be within the near field and thetwo may communicate and pair, i.e., communication enable.

In some embodiments, the remote interface display/screen may indicate tothe user the scheduled delivery trajectory together with the actualvolume delivered. This may increase the user's awareness of the amountof fluid being delivered by the infusion pump and therefore enable theuser to make more educated therapy decisions. Further, the actual volumedelivered may be helpful for health care providers in tweaking orperfecting basal levels, insulin to carbohydrate ratios, etc.

In some embodiments, as the remote interface may appear to be anordinary device rather than a medical device, the remote interface mayinclude password protections required for changing therapy. For example,to open the “therapy screens”, which term may be used to refer to anyscreen capable of making any changes to therapy, including, but notlimited to, insulin/drug sensitivity, carbohydrate to drug ratios,duration of drug, basal profiles, bolus requests, food libraryinformation, blood glucose screens, etc., the user may, in someembodiments, be required to enter a password. In some embodiments, afinger print or other may be used. In some embodiments a “tap code”,i.e., force being applied to the remote interface at an interval, may beused (e.g., in embodiments where the remote interface 1800, 1900 mayinclude at least one accelerometer, tapping on the device in specificcodes may convey information. In some embodiments, in addition or ratherthan the remote interface 1800, 1900 having the at least oneaccelerometer, the infusion pump 1802, 19002 may include at least oneaccelerometer.).

In some embodiments, where the remote interface is web enabled and/orBLUETOOTH® enabled, where one or more devices (e.g., the CGMsensor/transmitter 1804, 1904, the infusion pump 1802, 1902, the bloodglucose meter 1806, 1906) experiences a problem, the user may send theengineering logs for that particular device directly to the manufacture.This may be desirable as it may save the user from having to mail thedevice experiencing a problem to the manufacturer. The manufacture, uponreceipt, may recommend a code or other to the user to clear the alarm orother once the manufacture has determined the cause of the problem. Insome embodiments, the remote interface may include a preprogrammedprotocol to only send the engineering logs to the manufacture and notthe medical information. This may ensure the user does notunintentionally send their secure medical information to themanufacturer. Thus, the remote interface 1800, 1900, in someembodiments, includes the logs and/or information for all of the devicesconnected to the remote interface 1800, 1900. Thus, replacing a devicemay be accomplished by downloading, from the remote interface 1800,1900, the logs, user profiles, user preferences, etc., such that thedevice may be used with minimum “set-up” time by the user and thereplacement device may function/be configured exactly as the old devicethat was replaced.

In some embodiments, it may be desirable to send the screen, e.g.,“screen shot”, from the remote interface 1800, 1900 to a service personand or manufacturer, i.e., the service person may be able to see thescreen while discussing any problems with the device e.g., either over aweb chat and/or on the phone.

In some embodiments, the manufacture may send the remote interface 1800,1900 a “video” or a link to a web site for instruction on correcting thedevice. In some embodiments, the “video” or other animations may beavailable on the remote interface 1800, 1900 itself which may include,but is not limited to, video or animation to show/describe and/or “walk”the user and/or caregiver through, attending to an alarm and/or otheraction with regards to a device 1802, 1902, 1804, 1904, 1806, 1906and/or a remote interface 1800, 1900 of the device (see FIGS. 29A-29Ffor examples of some embodiments).

Further, in some embodiments, the remote interface 1800, 1900 mayinclude the capability to compile a list of approved addresses forsending secure information, which may include, but is not limited to,medical information. Thus, where the user unintentionally enters anincorrect email address or web address, etc., the remote interface 1800,1900 may prevent the user from being able to send the secure informationwithout further steps, which may include, for example, entering the newaddress onto the approved address list. In some embodiments, alterationsto the list may be password or other (tap, fingerprint, etc.) protected.

In some embodiments, the status of one or more of the devices (i.e., CGMsensor/transmitter 1804, 1904 and/or infusion pump 1802, 1902 and/orblood glucose meter 1806, 1906) may be indicated through audio soundsthrough an ear phone connected to the remote interface 1800, 1900 and/ora speaker on the remote interface 1800, 1900, which may include, but isnot limited to, current glucose reading.

In some embodiments, a device 1802, 1902, 1804, 1904, 1806, 1906 maycommunicate with the remote interface 1800, 1900 using an acousticsignal coupled with a radio signal to indicate the proximity of one ormore of the devices, so called “thunder and lightning”. In someembodiments, a message may be sent by a first device to a second deviceusing a radio signal. This radio signal may be coupled together with anultrasonic “churp” at the same time. This may be used to determineand/or calculate the distance between the devices. This method may beused to ensure the message being sent and/or request made by forexample, a remote interface 1800, 1900, is within an appropriatedistance from the device which may be indicative of whether the user ofthe devices's remote interface 1800, 1900 is sending the message orindicate whether another (i.e., non-user) remote interface and/or deviceis sending a message. This may be used to ensure safety incommunications and control of one or more of the devices by the remoteinterface 1800, 1900. For example, where a user is sending asignal/communication from their remote interface 1800, 1900 to theirinfusion pump 1802, 1902, this may ensure that the user is wearing theinfusion pump 1802, 1902, as it is unlikely the remote interface 1800,1900 would be more than a particular distance from the infusion pump1802, 1902, e.g., 4 feet. Thus, where the system determines and/orcalculates, using the above described method, that the remote interface1800, 1900 is greater than a threshold (which may be, in someembodiments, pre-determined and/or pre-set either by the manufacturerand/or by the user, which threshold may be, in some embodiments, basedon, e.g., the user's own measurements and/or the length of the tubing)distance from the infusion pump 1802, 1902, the remote interface 1800,1900 may alert/alarm and/or notify the user. In some embodiments, thealarm/alert may also include a message stating that an unidentifieddevice is attempting communication with the infusion pump 1802, 1902.Thus, this may be one method of the remote interface 1800, 1900determining whether a communication being received and/or beingtransmitted to a device within the system is an “approved device”, i.e.,a device in which the user has incorporated into the system, i.e.,paired to the remote interface 1800, 1900 and/or paired to anotherdevice that may be paired with the remote interface 1800, 1900.

In some embodiments, a method to manage communication between nonapproved and approved devices may be as follows. When the remoteinterface 1800, 1900 sends out a message there is a known delay of theradio and response between the device and the remote interface 1800,1900. The delay between the time the device 1802, 1902, 1804, 1904,1806, 1906, for example, received the message to when it sends a messagemay be measured to determine the round trip time. This may be used todetermine the distance between the remote interface 1800, 1900 and thedevice 1802, 1902, 1804, 1904, 1806, 1906. Where the measured distanceindicates that the distance exceeds a pre-programmed threshold, then theremote interface 1800, 1900 may, in some embodiments, for example, alertand/or alarm the user.

In some embodiments, the information uploaded from the remote interface1800, 1900 to a web portal/personal computer 1808, 1909 may also besynchronized with an electronic calendar, for example, but not limitedto, an OUTLOOK calendar or other. Thus, events in the user's life may belinked to the data of the devices 1802, 1902, 1804, 1904, 1806, 1906connected to the system. This may be desired to indicate events thatoccurred and bring relevance and breadth to the data for analysis. Also,where the user may not have entered an event into the remote interface1800, 1900, but the event is on an electronic calendar, the events mayautomatically be entered with the data for review and analysis. Forexample, where the user's calendar may indicate “soccer practice”, butduring soccer practice, the user did not indicate an event on the remoteinterface 1800, 1900, upon uploading the data from the remote interface1800, 1900 to the web portal/personal computer 1808, 1908, the data fromthe remote interface 1800, 1900 may incorporate, into, for example, asoftware program designed to readily view information and data from thedevices, the event, “soccer practice”, for example, above the area of agraph representing the amount of fluid delivered (which may be the basalrate) and the blood glucose data, for example, data from the CGMsensor/transmitter 1804, 1904 and/or data from the blood glucose meter1806, 1906. Thus, the user may, in one representative graph, forexample, view drug delivery data, CGM and blood glucose data, togetherwith an indication of what the user was doing at the time.

Thus, the user may connect the remote interface 1800, 1900 to a personalcomputer 1808, 1908 and/or, in some embodiments, upload data from theremote interface 1800, 1900 to a web portal or other. In someembodiments, this may be accomplished during “recharging” of the remoteinterface 1800, 1900, which, in some embodiments, may be done using aUSB connection to the personal computer 1808, 1908, which, in additionalto charging/recharging the remote interface 1800, 1900 may synchronizeand/or upload/download data from the personal computer 1808, 1908 and/orweb portal. At this time, the system may determine software updates forone or more of the devices and or for the remote interface 1800, 1900are available. The user may select “download updates” and these may bedownloaded to the remote interface 1800, 1900, again, at the time ofcharging and/or at any time the remote interface 1800, 1900 is eitherconnected, directly or indirectly, to the personal computer 1808, 1908and/or to a web portal designed specifically for the system. Asdiscussed above, the remote interface 1800, 1900 is capable ofcommunication with the various devices. Thus, software updates may becommunicated to any one or more device by the remote interface 1800,1900. This has many advantages, including, but not limited to, onlyhaving to connect the remote interface 1800, 1900 to the personalcomputer/web portal 1808, 1908 to both upload data/information from allof the devices and/or download updates and/or applications from thepersonal computer and/or from the internet/web portal to any of thedevices. This may be desirable for many reasons, including but notlimited to, the ability to efficiently and easily update all devicesfrom one connection and/or the ability to view all of the data from allthe devices on one location and/or the ability to download informationand/or settings from the personal computer/web portal to any of thedevices through the remote interface.

Thus, in some embodiments, as the personal computer/web portal containsall the information from all the devices, including, but not limited to,the remote interface, at any time, a new “remote interface” may beintroduced to the system. This may be accomplished by connecting the newremote interface to the personal computer/web portal and downloading allthe information regarding the system to the remote interface. In someembodiments, this may first require that the old remote interface beremoved from “approved devices”, however, in other embodiments; thesystem may “allow” additional remote interfaces by permission from theuser. Thus, the system includes the ability to download all theinformation and applications to any internet connected and/or remoteinterface capable of communicating to the devices and/or capable ofconnecting the personal computer and/or web portal.

This also allows the remote interface to download any application fromthe internet to any device in the system. Thus, in various embodimentsof the system, a user can turn any apparatus (including some parameterssuch as ability to wirelessly communicate and connect to the personalcomputer and/or web portal) into a device that could control the variousdevice, for example, the infusion pump and/or receive data from and/orcontrol a CGM sensor/transmitter, and/or other analyte sensors, and/orother devices. In some embodiments, the remote interface and/or the oneor more applications on the remote interface may be password or otherprotected and is paired with the one or more devices, for example,paired with an infusion pump and/or CGM sensor and or one or more otherdevices.

In some embodiments, the information on the remote interface may beuploaded and/or synchronized with another device and/or a computerand/or machine, including, but not limited to, uploading the data to aninternet site that may be password protected (web portal). Thus, a usermay access the information from any device and or may download theinformation to any device including any device specific applications andtherefore the user information may be downloaded to any deviceincluding, but not limited to, history, preferred settings, etc.,information.

In some embodiments of the system, a blood glucose meter 1806, 1906 maybe included which may not include a user interface, but rather, only astrip reader and the minimum components to function. In someembodiments, the blood glucose meter 1806, 1906 communicates with theremote interface 1800, 1900 and the remote interface 1800, 1900 displayindicates the readings and/or in some embodiments, the remote interface1800, 1900 includes broader functions than the blood glucose meter 1806,1906, which may include, but are not limited to, graphicalrepresentations of the blood glucose meter 1806, 1906 readings and/orhistorical data as well as user preferences, etc.

Although the system as discussed above takes examples from an infusionpump system, in various embodiments, the device(s) may be any device(s),including any medical device, and/or there may be more than or less thanthe number of devices represented on the FIGS. shown.

As discussed above, in various embodiments, the remote interface 1800,1900 may include a tablet computer or a multifunctional webconnected/web enabled device, for example, in some embodiments, theremote interface may be a DROID RAZER. In some embodiments, one or moreperipherals may be turned off and/or may “sleep” while the remoteinterface is communicating with one or more of the devices in thesystem, for example, with a medical device. In some embodiments, theantenna and or the wireless communications software may be modified to aproprietary version, for example, as described above or in any of theinformation incorporated by reference. In some embodiments, the wirelesscommunications may be that in the remote interface device itself, forexample, BLUETOOTH low energy wireless communication protocol. In someembodiments, together with this communications protocol, a translatormay be included to translate to a proprietary protocol on one or more ofthe devices in the system. In some embodiments, the messaging may beaccomplished through the protocols discussed herein, or through similarprotocols and/or using protocols from the remote interface device.

The remote interface therefore, in various embodiments, includes adisplay assembly which may include a color touch screen. In someembodiments, the remote interface additionally includes at least oneswitch assembly. In some embodiments, the remote interface includesanimated “set-up” instructions for the one or more devices.Additionally, in some embodiments, the remote interface includes alarmrecovery and or alarm animations, which may include, but are not limitedto, instructions to the user for checking and/or confirming and/orrecovering from the alarm condition. These animations may include, butare not limited to, written/word instructions and/or audio instructions.In some embodiments, the graphical user interface may present differentcolor backgrounds to represent different conditions, for example, “red”for alarm, “blue” for idol, “green” for delivering/action, etc. In someembodiments, one or more of the above functions may additionally includesound/audio which may include, but is not limited to, audioinstructions, beeps, etc.

Referring now to FIGS. 20A-30 various “screen shots” are depicted whichserve as some embodiments of the graphical user interface for a remoteinterface for an infusion pump for example, for one of the embodimentsof the infusion pump described herein. In some embodiments, screen shotsare shown for the remote interface for a blood glucose meter. In someembodiments, the screens may be used as instructional interfaces.

Referring now to FIGS. 20A-22H, in some embodiments, the remoteinterface may include animations and/or pictorial/graphical instructionsto demonstrate to a user how to perform certain actions with respect tothe device. In some embodiments, these animations and/orpictorial/graphical instructions may include voice over and/or audioand/or may include text and written instructions. FIGS. 20A-22H includesome embodiments and/or examples of embodiments of a graphical userinterface (GUI) for setting up an infusion pump. These examples areshown as illustrative screen shots and various embodiments are notlimited to the words and/or pictures shown. Also, the order of thescreen shots may vary throughout the embodiments. Additionally, in someembodiments, the various screen shots may include one or more of thefollowing buttons: a “back”, “cancel” and/or “next” button. In theseembodiments, on any screen, the user may choose to go back, cancel thescreen and/or proceed to the next screen. In some embodiments where ananimation is included, the animation may replay indefinitely until andunless the user selects a button, for example, back, cancel and/or next.In some embodiments, a button may be highlighted and or de-highlighted(which may be represented as a dotted line in the Figures).

Referring now to FIGS. 20A-20M, graphical instructions for filling adisposable portion (which may also be referred to as a reservoir) andpriming the disposable portion are shown. Referring to FIG. 20A, someembodiments include at least one screen instructing the user to washtheir hands. In some embodiments, at least one screen is includedshowing a user washing their hands and may instruct the user to washtheir hands with soap and warm water. In some embodiments, a screen mayinclude an animation showing the user washing their hands with soap andwater. Referring to FIG. 20B, some embodiments include at least onescreen instructing the user to remove the cover and lid of thedisposable portion. In some embodiments, the screen may show thedisposable portion. In this embodiment, the screen shows an embodimentof a disposable portion in a packaging and instructs the user to removethe cover and lid from the package. In some embodiments, this embodimentis an animation and in some embodiments, the graphical animation showsthe cover and lid being removed from the package. Referring now to FIG.20C, some embodiments include at least one screen shot showing that thebase of the package is attached to the lid. In some embodiments, thisembodiment is an animation, and in some embodiments, the graphicalanimation shows the base of the package being attached to the lid.Referring now to FIG. 20D, some embodiments include at least one screenshowing the vial (of infusible fluid) being cleaned. In this embodiment,the screen shows an embodiment of a vial and an alcohol swab andinstructs the user to clean the top of the insulin vial with an alcoholswab. In some embodiments, this embodiment is an animation of the vialbeing cleaned with an alcohol swab. Referring now to FIG. 20E, someembodiments include at least one screen showing a syringe in a package.In this embodiment, the screen shows an embodiment of a syringe in apackage and instructs the user to remove the syringe from the packageand connect needle. In some embodiments, this embodiment is an animationof the syringe being removed from the package and the needle beingconnected. Referring now to FIG. 20F, some embodiments include at leastone screen showing the syringe and the vial. In this embodiment, thescreen shows an embodiment of a vial and a syringe and instructs theuser to fill the syringe with up to a 3-day supply of insulin; thereservoir can hold a maximum of 3 mL. Remove any air bubbles in thesyringe. In some embodiments, this embodiment is an animation of thesyringe being filled with insulin from the vial.

Referring now to FIG. 30 in some embodiments, at least one screen may beincluded that may show an embodiment of a syringe, filled with fluid(“filled” does not necessary mean to capacity, filled may be used torefer to any volume of fluid having been loaded into the syringe and/orreservoir) and a remote interface placed near the syringe, held by auser, and taking a picture of the syringe. In some embodiments, thisembodiment is an animation of the remote interface and a syringe, theremote interface taking a picture of the syringe. In some embodiments,at least one screen may instruct the user to take a picture of thesyringe. In some embodiments, when the user reaches this screen, theremote interface may automatically enter a camera mode such that theuser then sees the view finder in the display assembly and may take apicture of the filled syringe. In some embodiments, the remote interfacemay confirm whether the picture is acceptable. In some embodiments, whenthe remote enters camera mode from the “take a picture of the filledsyringe” screen, the camera mode may be an “autofocus” mode and/or maybe a proprietary camera mode that is designed to take the picture atsuch a resolution such that pattern recognition software, and in someembodiments, designed specifically for this task, may determine thefluid level in the syringe. In some embodiments, this recognitionsoftware may be similar to software used to read 2D bar codes. In someembodiments, the camera on the remote interface may be used for otherpurposes, for example, for scanning 2D barcodes, for example, on thedisposable portions and or on reusable portions (for example, in someembodiments, this may be used for pairing the device with the remoteinterface) and/or for scanning 2D barcodes on insulin and/or infusiblefluid vials and or other peripherals that may be used in variousembodiments of the system, whether the system includes an infusion pump.

Referring now also to FIGS. 31-34 , in some embodiments, a basal profilemay be entered into the remote interface using the camera in the remoteinterface 3004 and a bar code 3000, including, but not limited to, a 2Dbar code, examples of which are given for illustration purposes only,see item 3000 in FIG. 31 and item 3002 in FIG. 32 . In variousembodiments, the 2D bar code may be generated by prescription by auser's physician. In some embodiments, the 2D bar code may becommunicated to the user, mechanisms of communications which mayinclude, but are not limited to, providing a hard copy of the 2D barcode and/or providing the 2D bar code in an email and/or on a secure webportal, for example. In various embodiments, the camera in the remoteinterface 3004 reads the 2D bar code 3000, 3002. The 2D bar codeincludes an embedded prescription basal profile embedded into the 2D barcode which, when read by bar code reading software, provides theinformation needed by the remote interface to program the basal profile.An example of the information included in the 2D bar code may include isshown in FIG. 33 as 3006. The information may include, but is notlimited to, one or more of the following: user's name, date of birth,profile type, dates of validity of the profile, and the rates per hourgiven by time frame. In some embodiments, where the 2D bar code includesdates of validity, the remote interface may alert/alarm the user whenthe dates of validity are coming to a close so that the user may prompttheir physician to prescribe an updated basal profile 2D bar code to beentered as discussed above. In various embodiments, once the validity ofthe profile expires the remote interface may stop pumping until andunless an updated profile prescription is entered. In variousembodiments, a user may receive multiple 2D bar codes, each including adifferent basal profile, which may include, for example, but are notlimited to, weekday, weekend, exercise, sick day, etc. In someembodiments, a single 2D bar code may encode more than one basalprofile. In various embodiments, the system described above may use a 3Dbar code and in other embodiments, the system may use QR CODE or “quickresponse code”. This system may be beneficial for many reasons,including but not limited to, preventing or diminishing the instances ofmanual programming errors, for example, where the user is entering theprescription manually, there may be a transcribing error. However, usingthe 2D bar code, programming errors are eliminated and therefore, thesystem may be safer than manual entry. Additionally, the system may bebeneficial for the prescription may be emailed and/or availableelectronically to the user, for example, in a secure web portal. In someembodiments, the system may request the user enter a passcode/passwordbefore the system will read the 2D bar code. This may be beneficial toprevent the prescription bar code from being read and programmed intothe wrong remote interface. In some embodiments, once the remoteinterface 3004 reads the 2D bar code 3000, 3002, the remote interface3004 may display the basal profile in graphical form for the user toreview.

Referring now also to FIG. 34 , in some embodiments, the remoteinterface 3004 may, using the camera, take a picture of a basal profile3008 in graphical form, whether on paper or presented in an electronicformat, for example. The remote interface 3004, in some embodiments, mayinclude recognition software that may recognize the parameters of thebasal profile 3008 and may program the basal profile 3008 into theremote interface 3004 such that the intended basal profile 3008 isautomatically entered into the remote interface 3004. This system may bebeneficial for many reasons, including but not limited to, preventing ordiminishing the instances of manual programming errors, for example,where the user is entering the prescription manually, there may be atranscribing error. However, using the basal profile 3008 read by theremote interface 3004, programming errors are eliminated and therefore,the system may be safer than manual entry. In some embodiments, once theremote interface 3004 reads the basal profile 3004, the remote interface3004 may display the basal profile 3008 in graphical form for the userto review. In some embodiments, the system may request the user enter apasscode/password before the system will read the basal profile 3008.This may be beneficial to prevent the prescription basal profile frombeing read and programmed into the remote interface without the user'sconsent.

Referring now to FIG. 20G, some embodiments include at least one screeninstructing the user to fill the base reservoir. In some embodiments,the screen may show an embodiment of a syringe in the filling aid in thereservoir package and instructs the user to insert the syringe in thefilling aid and transfer the insulin to the base reservoir, do notremove the syringe yet. In some embodiments, this embodiment is ananimation of the syringe being inserted into the filling aid and theplunger moving towards the base to transfer the insulin the basereservoir.

Referring now to FIG. 20H, some embodiments include at least one screenshowing a syringe removing bubbles from a filled reservoir. In thisembodiment, the screen shows an embodiment of a syringe in the fillingaid in the reservoir package and instructs the user to check thereservoir for bubbles, draw any air bubbles back into the syringe. Insome embodiments, this embodiment is an animation of the user checkingfor reservoir bubbles and drawing the air bubbles back into the syringe.

Referring now to FIG. 20I, some embodiments include at least one screenshowing a syringe and a “sharps” container. In this embodiment, thescreen shows an embodiment of a user holding a syringe next to a sharpscontainer and instructs the user to remove the syringe and dispose ofthe needle in a sharps container. In some embodiments, this embodimentis an animation of the user removing the syringe and disposing of theneedle in a sharps container.

Referring to FIG. 20J, in some embodiments, a screen requesting the userenter the reservoir volume may be included. In some embodiments, asshown in FIG. 20J, a key pad may be included and the user may touch theappropriate number buttons so that the display, in units in someembodiments, reflects the volume of fluid that was transferred to thereservoir. In some embodiments, the system may compare the volumeentered to the volume determined from the image of the filled syringe.In some embodiments, if the two volumes are within a threshold of error,for example, + or −0.5 units, the system may rely on either one or theother, and in some embodiments, may rely on the user inpu (for example,the units input on the keypad in FIG. 20J). In some embodiments, theremote interface may ask the user to re-enter or “are you sure?” if thedifference between the two number exceeds a threshold. This may bedesirable a confirmation of the volume of fluid transferred to thereservoir.

Referring now to FIG. 20K, in some embodiments, the user interface mayinclude at least one confirmation screen with the reservoir volume andin some embodiments, may include a button to “modify reservoir volume”,which may, in some embodiments, take the user to a screen to input adifferent volume value, for example, the screen shown in FIG. 20J.

Referring now to FIG. 20L, some embodiments include at least one screeninstructing the user priming the disposable. In this embodiment, thescreen shows a thumb/hand pressing on the filling aid on the disposableportion/reservoir and a caption of an infusion set connector andinstructs the user to press and hold the prime button on the filling aiduntil a drop of insulin is visible at the infusion set connector. Insome embodiments, this embodiment is an animation of a thumb/handpressing and holding the prime button on the filling aid until a drop ofinsulin is visible at the infusion set connector.

Referring now to FIG. 20M, some embodiments include at least one screeninstructing the user to remove the filling aid. In this embodiment, thescreen shows a hands rotating the filling aid on the disposableportion/reservoir and instructs the user to remove the filling aid fromthe base by rotating the filling aid counter clockwise, discard thefilling aid. In some embodiments, this embodiment is an animation ofhands removing the filling aid from the base by rotating the filling aidcounter clockwise and discarding the filling aid.

Referring now to FIG. 20N, some embodiments include at least one screeninstructing the user to attach the pump to the base. In this embodiment,the screen shows a user attaching the pump to the base and includes aninsert/caption that may be an enlargement of a “lock” and “unlock”position icons and instructs the user to first remove the protectivedust cover or charger, then attach the pump to the base and rotate tothe locked position; the pump will play a confirmation tone when itdetects the base in position. In some embodiments, this embodiment is ananimation of hands first removing the protective dust cover or charger,then attaching the pump to the base and rotating to the locked position.

Referring now to FIG. 20O, some embodiments include at least one screeninstructing the user to push the pump button. In this embodiment, thescreen shows a user pushing a pump button on the reusable portion andinstructs the user to activate the pump by pushing and holding the pumpbutton; the pump button will play a sound when it is activated. In someembodiments, this embodiment is an animation of hands activating thepump by pushing and holding the pump button.

Referring now to FIG. 20P, some embodiments include at least one screeninstructing the user that the pump is activated. In this embodiment, thescreen shows a pump vibrating or playing a sound and instructs the userthat the pump has been activated and to press the next button tocontinue setup.

Referring now to FIG. 20Q, some embodiments include at least one screenrequesting the user start a pump test. In this embodiment, the screenshows a caution sign instructs the user to make sure the cannula is notconnected to the tubing set; the pump test will deliver a small amountof insulin. A button on the screen indicates the user should press tostart the pump test after they have yielded to the caution.

Referring now to FIG. 20R, some embodiments include at least one screenstating that the pump is performing the pump self-test. In thisembodiment, the screen shows a caution sign instructs the user to makesure the cannula is not connected to the tubing set; the pump test willdeliver a small amount of insulin and also states that the pump isperforming the pump self test; the test will generally take about oneminute.

Referring now to FIG. 20S, some embodiments include at least one screenstating that the pump test is complete. In this embodiment, the screenshows a “check mark” and instructs the user that the test passed; thepump and base are working properly; press the next button to continue.In some embodiments, the “back” button may become de-highlighted,indicating that the system suggest to continue to next or cancel, insome embodiments. Referring to FIG. 20T, some embodiments include atleast one screen instructed the user to insert the infusion setaccording to the manufacturer's instructions.

Referring now to FIG. 21A, some embodiments include at least one screeninstructing the user to attach the VELCRO to the pump. As describedabove, in some embodiments (for example, as described and shown withrespect to FIG. 3 ), the disposable portion may include an adhesivepatch which in some embodiments may include a VELCRO fastener system. Inthis embodiment, the screen shows a user touching the backing of thepatch on the back of the disposable and instructing the user to removethe backing and attach the smaller VELCRO patch to the back of the base.In some embodiments, this embodiment is an animation of hands removingthe backing and attaching the smaller VELCRO patch to the back of thebase.

Referring now to FIG. 21A, some embodiments include at least one screeninstructing the user to attach the VELCRO to the pump. As describedabove, in some embodiments (for example, as described and shown withrespect to FIG. 3 ), the disposable portion may include an adhesivepatch which in some embodiments may include a VELCRO fastener system. Inthis embodiment, the screen shows a user touching the backing of thepatch on the back of the disposable and instructing the user to removethe backing and attach the smaller VELCRO patch to the back of the base.In some embodiments, this embodiment includes an animation of handsremoving the backing and attach the smaller VELCRO patch to the back ofthe base.

Referring now to FIG. 21B, some embodiments include at least one screeninstructing the user to attach the patch to the user's body. Asdescribed above, in some embodiments (for example, as described andshown with respect to FIG. 3 ), the disposable portion may include anadhesive patch which in some embodiments may include a VELCRO fastenersystem that attaches to the body. In this embodiment, the screen shows auser touching the backing of the large patch and the large patch andinstructing the user to remove the backing and attach the larger VELCROpatch to their body; next, attach the pump to the VELCRO. In someembodiments, this embodiment is an animation of hands removing thebacking and attaching the larger VELCRO patch to the body and attachingthe pump to the patch.

Referring now to FIG. 21C, some embodiments include at least one screeninstructing the user to remove the infusion set cap. In this embodiment,the screen shows a user removing the infusion set cap and instructingthe user to squeeze the two tabs on the infusion set and removing theprotective cap. In some embodiments, this embodiment is an animation ofhands squeezing the two tabs on the infusion set and removing theprotective cap.

Referring now to FIG. 21D, some embodiments include at least one screeninstructing the user to connect the infusion set. In this embodiment,the screen shows a user connecting the infusion set to the cannula andinstructing the user to connect the infusion set to the cannula. In someembodiments, this embodiment is an animation of a hand connecting theinfusion set to the cannula.

Referring now to FIG. 22A, some embodiments include at least one screenfor priming the cannula. In this embodiment, the screen shows a primevolume and includes a button to start cannula prime and includesinstruct to verify that the cannula prime volume is correct and thenpress the start cannula prime button. A button on the screen indicatesthe user should press to start the cannula prime.

Referring now to FIG. 22A, some embodiments include at least one screenfor showing the cannula prime in progress. In this embodiment, thescreen shows the volume of prime delivered and a total prime volume andincludes a button to stop prime. The screen also includes a status barthat represents the volume delivered out of the total prime volumerequested.

Referring now to FIG. 22B, some embodiments include at least one screenfor confirming the cannula prime is finished. Referring to FIG. 22D,some embodiments include at least one screen for confirming the setup iscomplete and including a button to start basal. In some embodiments,this screen automatically appears after the setup is complete which maybe beneficial for many reasons, including, but not limited to, remindingthe user to start the basal on the infusion pump.

Referring now to FIG. 23A, some embodiments include at least one screenfor programming basal profiles. In the embodiment shown, to program thebasal profile, the user enters the rate, which, in some embodiments maybe the volume, in units, per hour, and the start and end time. Invarious embodiments, a user may create basal profiles for various days(for example, a Monday profile, etc), and/or for weekdays and/or forweekends and/or may create custom profiles for events (for example,skiing).

Referring now to FIG. 23B, some embodiments include at least one screenfor visually reviewing the basal profile for the day which may includeboth a graphical representation of a twenty-four hour period and also,an indication of the current rate for the time of viewing.

Referring now to FIGS. 23C and 23D, some embodiments include at leastone basal profile screen that includes buttons including each rateduring a range of time, for example, a twenty-four hour period. In someembodiments, a user may select a button representing one of the rangesof time and that will bring the user to a screen to edit that particulartime-frame. In some embodiments, the screen may additionally includeboth a graphical representation of the current basal profile and thecurrent time-frame on top.

Referring now to FIGS. 24A and 24B, in some embodiments, the remoteinterface may either be wirelessly connected to a blood glucose meterand/or may include a blood glucose meter. When the user takes a bloodglucose reading, in some embodiments, the screen shown in FIG. 24Aautomatically is visible. In some embodiments, the screen may include abutton that automatically presents a likely “tag”, for example, as shownin FIG. 24A, based on the time of day, the screen button indicates“lunch”. However, the user may edit this tag. For example, the user mayselect the button “add/edit” and the user may be brought to a screenthat is similar to the one shown in FIG. 24B. The edit note and tagscreen may include an area for custom editing (i.e. edit box), the usermay type comments into the edit box. The tag list may include customtags that the user may have pre-programmed into user settings either byusing the personal computer/web portal or by using the remote interface.In some embodiments, the settings for the GUI may include defaultlistings that may be edited.

Referring now to FIGS. 25A and 25B, some embodiments may include ascreen, as shown in FIG. 25A, where the user manually enters a bloodglucose reading. In some embodiments, after entering and selecting“next”, a label screen, for example, as shown in FIG. 25B, may allow theuser to select a label. The label list may include custom tags that theuser may have pre-programmed into user settings either by using thepersonal computer/web portal or by using the remote interface. In someembodiments, the settings for the GUI may include default labels thatmay be edited.

In some embodiments, upon manually entering a blood glucose value, forexample, using a screen such as one shown in FIG. 25A, the userinterface may indicate the amount of carbohydrates the user shouldconsume. For example, if the user enters “40 mg/dL”, the system may, byusing the correction information that is entered with respect to a userprofile (i.e., the amount of carbohydrates used treat low blood glucoselevels/hypoglycemia, which may be determined by a user together withtheir health care provider), may computer the amount of carbohydrates totreat hypoglycemia. In some embodiments, the remote interface may bepreprogrammed with specific instructions to treat hypoglycemia, forexample, with fifteen skittles (for example, or any other candy orglucose item) and four ounces of apple juice (in some embodiments,however, these may vary) (all of which may be entered by the user intothe user profile either through the remote interface or the personalcomputer/web portal) and, the user interface may show a picture of thefood, for example, the 15 skittles and/or four ounces of apples juice,to the user upon entering a hypoglycemic glucose number (which numbermay be pre-programmed into the system). In some embodiments, the usermay request additional suggestions which may also be presented to theuser on the GUI in the form of words and or pictures. This may bedesirable for many reasons, including but not limited to, quick and easytreatment of hypoglycemic events, where a user will quickly decipher thefood they should eat to treat the hypoglycemic event and/or the user mayshow a friend or another person the picture and request they providethat food. In some embodiments, this may be beneficial especially incountries where the user may not speak the local language.

Referring now to FIG. 25C, some embodiments may include at least oneglucose history screen, which may, in some embodiments, include alisting of the times and the glucose readings. In some embodiments,additional information may be readily available either on a screen suchas this, or if the user selects a reading, another screen with moredetail may be included, for example, the food eaten and/or the activityand/or the label and/or the tag, or any other indication that the userhas tagged or labeled to the reading. In some embodiments, a “graph” tabmay be accessible from the glucose screens to view a graph of bloodglucose values. In some embodiments, the graph may be interactive andthe user may touch points or locations on the graph that will take theuser to a screen including more detail for that entry and or period oftime, etc. In some embodiments, the GUI may show continuous glucosemonitor (CGM), blood glucose meter (BGM) and infusion pump volumes onthe same graph.

In some embodiments, the graphical user interface may include one ormore screens for programming a bolus. Referring now to FIGS. 26A-26D, insome embodiments, a user may enter select a good from a food library,which, as discussed above, may include custom entries by the user(either using the remote interface and/or downloading food library fromthe web and/or completing custom entries on the personal computer and/orweb portal and downloading/synchronizing with the remote interface)and/or may include default entries. In some embodiments, the user maynavigate to the food library screen(s), for example, in some embodimentsthe screens may be similar to the screens shown in FIGS. 26K And 26L,select the food and/or select “keypad” and type the food into the searchscreen, and then another screen, for example, in some embodiments, theone shown or similar to the one shown in FIG. 26A, may request the userenter the quantity of the food. In some embodiments, the screen may alsoinclude indications of the nutritional value of the food, for example,which may include, but is not limited to, one or more of the following:carbohydrates, fat and/or calories. In some embodiments, where a food isnot selected from the food library, a confirmation screen will indicatesame to the user, which, in some embodiments, may be similar to theembodiment of the screen shown in FIG. 26M.

In some embodiments, the user may enter the carbohydrate amount using akeypad, which, in some embodiments, may be similar to one shown in FIG.26D. In some embodiments, once the user has entered a food items, theuser may return to add additional items, for example, by using a buttonsimilar to that shown in the screen shown in FIG. 26J, where the usermay select the “add food/carbs” button. Once the user has added all thecarbohydrates, including food items, for the bolus, the user may select“ok” and a screen, which may be similar to the one shown in FIG. 26B,may indicate to the user that the remote interface is establishingwireless communication with the infusion pump.

In some embodiments, the user may select to enter the units of insulinrequested for a bolus, rather than enter the carbohydrates or the fooditems and quantity. In some embodiments, this may be accomplished usinga keypad screen, for example, which may be similar to the screen shownin FIG. 26N. Once the user has entered the volume requested, the usermay select “ok” and a screen, which may be similar to the one shown inFIG. 26B, may indicate to the user that the remote interface isestablishing wireless communication with the infusion pump.

In some embodiments, during the bolus process, the remote interface mayshow a screen that includes the most recent blood glucose meter result,which may, in some embodiments, indicate to the user the time the testwas taken and also, the time elapsed since the test. In someembodiments, the screen may be similar to the screen in FIG. 26H. Insome embodiments, the screen may instruct to user to confirm whetherthey want a bolus calculator to use this recent glucose test for thecorrection portion of the bolus. The user may, in some embodiments,select “no, retest”, in which case the user interface may open the bloodglucose meter screens. In some embodiments, the user may select “no,skip correction bolus”, in which case the bolus calculator will not usethe value and will not bring the user to the blood glucose meter screensautomatically. In some embodiments, the user may select “OK” and thebolus process may continue.

In any case, once the user has entered all of the information they wishto enter regarding the bolus, which may include, but is not limited to,one or more of the following: carbohydrate values, food items, bloodglucose values and/or units of insulin volume requested, the userinterface presents a summary screen, for example, which may be similarto the embodiment shown in FIG. 26I, that indicates, in someembodiments, the recommendation for each of the bolus categories, forexample, meal bolus (for food), correction bolus (for glucose) andindicates to the user the bolus on board (which in some embodiments, maybe termed the insulin on board or JOB), and indicates a total bolusrecommended. The user may navigate from this window and adjust the totalbolus to be delivered, for example, by touching the “total bolus” areaof the screen and adjusting the value in units. In some embodiments,this may be done using a keypad. In some embodiments, this may be doneusing a slide adjust GUI, which, I some embodiment, may be similar tothe one shown in FIG. 26G. In this embodiments, the total amountrecommended, e.g., 3.51 units, is shown in the “modify bolus amount” box2600. The user may, by moving the slider 2602, adjust the total volume.As, for example, the user slides the slider 2602 towards the left, boththe total amount in the modify bolus amount box 2600 decreases and thepercentage decreased is represented in the modify bolus amount box 2600.As, for example, the user slides the slider 2602 towards the right, boththe total amount in the modify bolus amount box 2600 increases and thepercentage increased is represented in the modify bolus amount box 2600.This may be desirable for many reasons, including, but not limited to,if a user desired to reduce or increase the recommended bolus amount bya given percentage, for example, reduce by 20% for pre-exercise and/orincrease by 40% for illness, the modify bolus amount box 2600 makes thiscalculation easy for the user.

Once the volume to be delivered is determined, in some embodiments, theuser interface presents a screen that allows the user to determine the

However, if the user wishes to proceed from the review recommendationscreen, the user may navigate, in some embodiments, using the “next”button. If the user is navigating from the modify bolus amount screen,the user may, in some embodiments, use the “OK” button. In someembodiments, the user will be brought to a screen allowing the user todetermine how the bolus is to be delivered, i.e., as a normal, extendedor as a combination. Referring now to FIGS. 26E and 26F, the totalvolume of insulin to be delivered, in some embodiments, may be, as adefault, delivered as a normal bolus, unless the user modifies to add atleast a percentage to be delivered as an extended bolus. In someembodiments, upon entering the screen shown in FIG. 26E, the normal 2604may include the total amount recommended and the extended 2608 mayinclude 0.00 units. The total units 2606 to be delivered may be shownunder the slider 2610. The normal 2604 and the extended 2608 may alsoinclude percentages, which in some embodiments, represents thepercentage of the total that will be delivered in that fashion, i.e.,either normal or extended.

The user may, by moving the slider 2610, adjust total volume that may bedelivered as normal 2604 and extended 2608. As, for example, the userslides the slider 2610 towards the left, both the total amount and thepercentage of the total in the normal 2604 increases. The total amountand the percentage of the total amount in the extended 2608 decreases.However, as, for example, the user slides the slider 2610 towards theright, both the total amount and the percentage of the total in theextended 2608 increases. The total amount and the percentage of thetotal in the normal 2604 decreases. This may be desirable for manyreasons, including, but not limited to, if a user desired to deliver aparticular percentage as an extended, for example, if the user desiredto deliver 80% as extended, the user may slide the slider 2610 to theright until the percentage in extended 2608 shows “80%”. Also, if a userdesires to deliver a particular volume, for example, 1.0 units, asnormal, which may be desired in many situations, including, but notlimited to, where the user desires to deliver the volume in the totalthat is attributed to correction bolus as normal, the user may slide theslider 2610 towards the right until the volume in the normal 2604 is1.00 units. In some embodiments, the direction of the slider 2610 withrespect to the increase or decreasing amounts under the normal 2604 andor the extended 2608 may vary.

Referring now to FIG. 26F, if any percentage or volume of the bolus isselected to be delivered as an extended, in some embodiments, a screensimilar to the one shown in FIG. 26F, may be presented to the user afterselecting “next” from the normal and extended bolus amount screen. Theuser may enter the amount of time they wish the extended volume (fromFIG. 26E) to be delivered over as an extended bolus. In someembodiments, as the user slides the slider 2612 to the right, the timefor the extended bolus increases and as the user slides the slider 2612to the left, the time for the extended bolus decreases. In someembodiments, the direction of the slider 2612 with respect to theincrease or decreasing of the time may vary. In some embodiments, theduration screen, such as the one shown in FIG. 26F, may open with adefault time, for example, 1 hour, and allow the user to modify. In someembodiments, the default may be the most recently programmed extendedbolus.

Once the user has programmed the method for delivery of the bolusvolume, the user may select “OK” in some embodiments, and a review bolussetting screen may be viewable, for example, in some embodiments, onesimilar to the one illustrated in FIG. 26C. In some embodiments, thereview bolus setting screen provides the total bolus amount to bedelivered, the method of delivery, the volume of the total that is to bedelivered as normal and the volume of the total that is to be deliveredas extended, and if there is a volume to be delivered as extended, theduration of the extended bolus may be indicated. The user therefore hasan opportunity to clearly review the bolus volume and the method ofdelivery. In some embodiments, to start the bolus delivery, the usermust “slide” the “confirm” button. This may be desirable for manyreasons, including but not limited to, a potentially decreased incidenceof accidental or unintentional tapping of the “confirm” button. Thus,the action, i.e., tapping, to “cancel” using the cancel button is acompletely different action from “confirm”, i.e., sliding. Also, thelocation of the “confirm” button and slide being in a very differentlocation from the “cancel” button may prevent unintentionalcancellation. Thus, this method may decrease unintentional cancellationand also, unintentional delivery when cancellation was desired. Also, insome embodiments, the location of the “next” or “ok” button is in asimilar location on many screens. Therefore, to prevent unintentionalconfirmation when a therapy change is being made, in some embodiments,the system requires a different action, for example, a slide rather thana touch/tap and in addition, in some embodiments, the start of the slideis in a opposite side from the “next” or “ok” buttons.

There are many advantages to this method of programming a bolus volume,including, but not limited to, the following. The user may firstdetermine the volume of bolus and then, following, determine the methodof delivery. Thus, a user does not have to decide that the bolus is“extended” before, for example, entering the carbohydrates/food and/orblood glucose value, for, as mentioned above, in some circumstances, auser may wish to deliver the food bolus portion of the total bolus as anextended bolus and the correction portion of the total bolus as a normalbolus. Also, the slider embodiments shown in FIGS. 26G, 26E and 26Fallow for the user to view the percentage change as well as the totalvolume at any given time. This method therefore may preventmiscalculations and allow for closer tweaking and customization ofinsulin therapy. Also, with respect to the user programming the durationof the extended bolus after entering the portion of the bolus volume tobe delivered as an extended bolus, the user may be less likely to“confirm” a delivery before modifying the duration.

Referring now to FIGS. 27A, 27B, 27C and 27E, in various embodiments,the user interface includes various opportunities for the user to cancelan action. In some embodiments, when the button “cancel” is pressed,another screen pops up that confirms that the user wishes to cancel.This may be desirable, for example, in the case where a userunintentionally taps the cancel button, the user has an opportunity tocontinue, rather than cancel.

Referring now to FIGS. 27F and 27G, in some embodiments, while a bolusis active, for example, in the above example, a portion of the bolus maybe delivered as normal and a portion may be delivered as extended, theuser interface may include a “delivering” screen indicating the statusof the active delivery. For example, in some embodiments, as shown inFIG. 27F, the volume delivered and the total volume to be delivered 2716may be indicated, as well as a status bar 2714 representing the volumedelivered as a function of the total volume to be delivered. Inaddition, in some embodiments, the delivering screen may also includethe current basal profile 2718, which may indicate both the name of theprofile, e.g., “weekday”, and the pre-programmed basal rate, e.g., 0.82units/hour.

In some embodiments, while a bolus is active, the home screen for theuser interface may change to a bolus delivery status screen ordelivering screen, for example, in some embodiments, may be similar tothe delivering screen shown in FIG. 27F. In some embodiments, wheneveran active bolus is being delivered, the home screen (which, in someembodiments, as described above, may be similar to a delivering screen)freezes and does not time out.

In some embodiments, while the infusion pump is delivering, thedelivering screen and/or the various screens of the user interface, mayinclude a different splash screen and/or background screen to indicate,visually, to the user that the delivering is occurring. In someembodiments, the background may be “green” to indicate delivering.However, this is just one embodiment, and other embodiments to indicateand/or differentiate the infusion pump status may be used.

Still referring to FIG. 27F, in some embodiments, while the infusionpump is delivering a bolus, a “stop bolus” button 2720 may be includedon the delivery screen. In some embodiments, the stop bolus button 2720may be a different color from the rest of the screen, for example, insome embodiments; the stop bolus button 2720 may be red.

Referring now to FIG. 27G, in some embodiments, while an active bolus isbeing delivered, if the user elects to “stop basal”, a stop basal pop upscreen 2722 may appear that asks the user to confirm that they wish tostop delivering basal insulin and reminds the user that this will alsostop the current bolus delivery. In some embodiments, the infusion pumpmay not allow the user to stop basal unless they also stop bolus, asthis may be desirable for if a user wishes to stop delivering of thebasal insulin, it may indicate that all insulin delivery should cease.The stop basal pop up screen 2722 reminds users that a bolus deliveringis in progress in case they did not realize when the elected to startthe process to “stop basal”.

Referring now to FIGS. 27H and 27I, in some embodiments, while an activebolus is being delivered, if the user elects to “stop bolus”, a stopbasal pop up screen 2724 may appear that asks the user to confirm theywish to stop delivering basal insulin. In some embodiments, the infusionpump may not allow the user to stop bolus unless they also stop basal,as this may be desirable for if a user wishes to stop delivering of thebolus insulin, it may indicate that all insulin delivery should cease.Referring to FIG. 27H, in some embodiments, if the user chooses tocancel the bolus, a confirmation screen of the cancellation may appearand indicate the units delivered out of the total volume programmed2726.

Referring now to FIG. 28A, an embodiment of a home screen is shown. Inthe embodiments shown, the home screen indicates a number of differentinformation, and in some embodiments, the amount of information on thehome screen may vary. However, in some embodiments, the followinginformation may be included on the home screen, however, in variousother embodiments, one or more, of the following information and/oradditional information may be included: indication of the infusion pumpstatus, e.g., the infusion pump is delivering 2800; indication of theactive basal profile 2802; indication of the bolus on board 2804;indication of the last glucose result 2806 which, in some embodiments,includes the time of the last result; the volume of insulin remaining inthe reservoir 2808; the percentage of pump battery life remaining 2810;the batter income 2814 (which may include a battery level indication);the current time 2818; the connectivity status 2816; and the section ofthe user interface in which the page resides 2812.

In some embodiments, as discussed above, while the infusion pump isdelivering, the screen may include a backsplash, icon or otherindication that readily indicates that status, for example, thebacksplash of the page may be a different color depending on the status.In some embodiments, the delivering status may be green, the glucosestatus may be orange, the alarm status may be red and the idle statusmay be blue. In these embodiments, irrespective of the screen, thestatus of the infusion pump may be learned by the user. Embodiments ofalarm status screens may be found in FIGS. 29A-29F, embodiments of anidle screen may be found in FIG. 28C. In some embodiments, when theinfusion pump is idling, that indicates there is no delivery, which, inmany circumstances, may not be desired for an extended period of time.Therefore, in some embodiments, when the infusion pump is in idle, thehome screen indicates the idle status 2828 and the idle status homescreen includes a large button for “start basal” 2830.

In some embodiments, one or more screens may include icon buttons fornavigation to particular screens, for example, home 2812, glucose 2820,bolus or basal 2822, logbook 2824 and/or settings 2826. Examples of oneembodiment of these screens are shown as follows: home, FIG. 29A,Glucose, FIG. 28B, Insulin (e.g. bolus or basal) FIG. 28D-28G, LogbookFIG. 28H and/or Settings FIG. 28I.

Referring now to the embodiments of the insulin screens, FIGS. 28D-28G,in some embodiments, the insulin screens include one or more, but notlimited to, the following buttons: bolus calculator 2830, program bolus2832, program basal 2834 and stop basal 2836. In some embodiments, theinsulin screens may also include an indication of the last bolus 2838which may include the volume and the time, as well as the currentlyactive basal profile 2840 which may include the rate and the profilename.

Referring now to FIGS. 29A-29F, embodiments of an occlusion detectedalarm is shown. In some embodiments, as discussed above, an alarmcondition may translate to a different backsplash/background or color,i.e., the backsplash of the screens may be red to indicate alarmcondition. In some embodiments, when an alarm condition is sensed by thesystem, the system may provide a series of GUI screens that aid the userin recovering and or confirming the alarm condition. For example, inFIG. 29A, in some embodiments, the screen may indicate that the flow ofinsulin is blocked and therefore, an occlusion condition exists. In someembodiments, the user may select “next” and the GUI may walk the userthrough recommended actions. For example, in some embodiments, forexample, in FIG. 29B, the screen may remind the use to check their bloodglucose. Referring to FIGS. 29C and 29D, the screens may instruct theuser to start the pump test (to determine if, for example, the occlusionis in the disposable portion or in the cannula). The pump test maydetermine, in some embodiments, if the disposable portion has anocclusion. Before starting the pump test, in some embodiments, thescreen reminds the user to disconnect from the tubing set. Referring nowto FIGS. 29E and 29F, in some embodiments, the system may determine thatthe occlusion is not within the disposable portion and may remind theuser to replace the cannula. In some embodiments, the system mayautomatically start a series of screens, which, in some embodimentsinclude those describe above, and in some embodiments, includeanimations, that remind the user to connect to the new cannula (andprime the new cannula, etc.). In some embodiments, where the systemdetermines the occlusion is in the disposable, the system may instructthe user to replace the disposable portion.

Various embodiments of the system therefore include one or more devicesand a remote interface. In some embodiments, the remote interface isconfigured to connect with and may communicate with a web portal and ora personal computer. In some embodiments, the remote interface may be apersonal computer.

In some embodiments, the system includes a recharging apparatus and/ordevice for recharging the remote interface and/or for recharging the oneor more device. In some embodiments, during recharge, the device and/orthe remote interface may receive software updates/software downloadsand/or synchronization with a database. In some embodiment, therecharging device and/or the charger includes a USB connection to apersonal computer, the connection may be used as a data port and/or as acharging apparatus.

In some embodiments, the system includes at least two reusable portionsof an infusion pump and/or other device, wherein, in some embodiments,both are configured to receive information and/or to communicate withthe remote interface. In some embodiments, while one of the two reusableportions is being recharged, the second of the two reusable portions maybe in use. Changing from one reusable portion to the second reusableportion may include the remote interface synchronizing data with thesecond reusable portion such that the second reusable portion includesupdated information once in use. In some embodiments, each of thereusable portions includes nonvolatile memory and may include all thecontrol and command capabilities with respect to one or more processors,which command the device. Thus, in some embodiments, the remoteinterface may be used as an user interface and commands, instructionsand profiles may be input by the user using the remote interface,however, those commands are sent to the device, and in some embodiments,the device, after confirming, with the remote interface, that the devicehas received the information correctly, the device commands all action,for example, the infusion pump commands delivery of infusible fluid.

In some embodiments, for the user to change use from a first reusableportion to a second reusable portion, the user may indicate to theremote interface they wish to change reusable portions. The firstreusable portion, in use, sends the current insulin on board and/orbolus on board (which may be referred to as JOB) information to theremote interface. The remote interface receives this information andstarts counting time with respect to the IOB information. Once thesecond reusable portion is connected to the remote interface, the remoteinterface sends the IOB information to the second reusable portion, withthe time stamp. The second reusable portion confirms the time on the IOBinformation. If the reusable portion finds that the time stamp does notmatch (which, in some embodiments, may be an indication that the firstreusable portion's battery is not functioning properly and/or was 100%out of charge when placed on charger), a message is sent to the remoteinterface that appears to the user that the time does not match. Theuser may enter in the correct time and this time for both the remoteinterface and the reusable portions. However, where the time stampmatches, the second reusable portion may rely on the IOB information andtherefore, the IOB calculations may be continuous, even while changingfrom a first reusable portion to a second reusable portion. In instanceswhere the time stamps do not match, in some embodiments, the IOBinformation may be deleted, and the calculations begin at 0 from the newset time, and the user is informed of same using the remote interface.

The remote interface may be used to communicate with at least onedevice. In some embodiments, the remote interface may be used tocommunicate with a variety of devices. This may be desirable for manyreasons, including, but not limited to, user familiarity. Using a singleremote interface, the software platforms of which may be designed, andin many embodiments are designed, to be similar in nature, such that asingle user may master a variety of software/applications for a varietyof devices without significant learning time. Additionally, the remoteinterface may, while either connected by way of a USB to a personalcomputer and/or while connected to web portal, may download all softwareupdates for all of the device in which it may be communicating with, andthen, may transfer these updates to the devices themselves. This may bebeneficial for many reasons, including, but not limited to, maintainingthe devices in a streamline process and for updating the devices in anefficient manner.

Additionally, using various software applications which may, in someembodiments, be loaded onto the personal computer and/or accessedthrough a web portal, a user may configure the various profiles and orreview various data regarding the devices in one location. Changes madeto the information and or to the profiles may be downloaded onto theremote interface. Any relevant changes are then wirelessly communicatedto the device(s). In some embodiments, the devices themselves mayreceive information by way of a USB connection to a personal computer.

In some embodiments, the remote interface may be used to capture imagesthat aid in the control of the devices. For example, in someembodiments, the user may be instructed to take a picture, using thecamera on the remote interface, of a filled syringe, such that theremote interface (and user interface) may either verify user enteredinformation regarding the volume of fluid in the filled syringe and/ordetermine the volume of fluid in the filled syringe. This may bebeneficial for many reasons, including, but not limited to, includingapproximately the correct volume of fluid that is loaded into areservoir, in some embodiments, may lead to greater safety for the user.In some embodiments, the infusion pump determines the volume of fluidremaining in the reservoir and alarms the user when the volume is lessthan a particular, and in some embodiments, pre-programmed, volume. Inthese embodiments, the user may change the reservoir (i.e., replace witha filled reservoir) before the volume is completely depleted. Thus, thisprevents the user from having an event where they have no medication.Thus, where an incorrect volume of fluid is entered, by the user, ashaving been transferred to the reservoir, the calculation of the volumeof fluid in the reservoir may be inaccurate. This may not be desired formany reasons, including, but not limited to, where the volume of fluidtransferred to the reservoir is miscalculated to a higher number, thenthe reservoir may be depleted faster than calculated and therefore, theuser may have no medication in an unpredictable manner. However, wherethe volume of fluid transferred to the reservoir is miscalculated to alower number, then the reservoir may be depleted slower than calculatedand therefore, the user may replace the reservoir prematurely and thus,discard un-used fluid.

In some embodiments, a camera may be used as described above, but thecamera may be part of a peripheral device to the remote interface. Insome embodiments, the peripheral device may transfer the image to theremote interface and the remote interface may process the image in asimilar manner as if it were provided by the remote interface's camera.

Referring now also to FIGS. 51A-51B and FIG. 53 , in some embodiments,the user may pre-program “preset bolus” amounts for various times ofday, events and/or meals. For example, in some embodiments, whenentering a bolus, the user may select a preset bolus, which, forexample, may include “Breakfast”, “Lunch”, or “Dinner”, each having apre-set amount as well as a pre-set delivery mode, which may include,but is not limited to, e.g., normal bolus, dual bolus, square wavebolus. In some embodiments, when a user has navigated to the bolusscreen, the last bolus given is indicated, as well as the time elapsedsince the last bolus. The menu may present to the user the option tonavigate to the “Bolus Wizard”, the “Manual Bolus” or the “PresetBolus”.

While the principles of the invention have been described herein, it isto be understood by those skilled in the art that this description ismade only by way of example and not as a limitation as to the scope ofthe invention. Other embodiments are contemplated within the scope ofthe present invention in addition to the exemplary embodiments shown anddescribed herein. Modifications and substitutions by one of ordinaryskill in the art are considered to be within the scope of the presentinvention.

What is claimed is:
 1. A medical device system comprising: a firstmedical device; a first remote interface; and a second remote interface,located separate from the first medical device and the first remoteinterface, in communication with the first remote interface and thefirst medical device, wherein the first remote interface: initiates acommand related to the communication of safety critical information tothe first medical device based on an input; displays a message on thefirst remote interface that the communication of the safety criticalinformation to the first medical device requires confirmation using thesecond remote interface; sends the communication to the second remoteinterface; and once confirmation is received by the second remoteinterface, the second remote interface communicates the command to thefirst medical device.
 2. The medical device system of claim 1, whereinthe first medical device is an infusion pump.
 3. The medical devicesystem of claim 1, wherein the first remote interface is a medicaldevice data system.
 4. The medical device system of claim 1, wherein thefirst medical device sends a command to the first remote interfacethrough the second remote interface.
 5. The medical device system ofclaim 1, wherein the system further comprising a blood glucose meter incommunication with the second remote interface.
 6. The medical devicesystem of claim 1, wherein the system further comprising a continuousglucose monitor transmitter in communication with the second remoteinterface.
 7. The medical device system of claim 2, wherein the firstremote interface: receives an input of information related to thedelivery by the infusion pump of a bolus volume of infusible fluid;displays a message that the delivery of the bolus volume requiresconfirmation using the second remote interface; and once confirmation isreceived by the second remote interface, the second remote interfacecommunicates the information required for the delivery of the bolusvolume of infusible fluid to the infusion pump.
 8. A medical devicesystem comprising: an infusion pump; a first remote interface comprisinga medical device data system; and a second remote interface, locatedseparate from the infusion pump and the first remote interface, incommunication with the first remote interface and the infusion pump,wherein the first remote interface: initiates a command related to thecommunication of safety critical information to the infusion pump basedon an input; displays a message on the first remote interface that thecommunication of the safety critical information to the infusion pumprequires confirmation using the second remote interface; sends thecommunication to the second remote interface; and once confirmation isreceived by the second remote interface, the second remote interfacecommunicates the command to the infusion pump.
 9. The medical devicesystem of claim 8, wherein the infusion pump sends a command to thefirst remote interface through the second remote interface.
 10. Themedical device system of claim 8, wherein the system further comprisinga blood glucose meter in communication with the second remote interface.11. The medical device system of claim 8, wherein the system furthercomprising a continuous glucose monitor transmitter in communicationwith the second remote interface.
 12. The medical device system of claim8, wherein the first remote interface: receives an input of informationrelated to the delivery by the infusion pump of a bolus volume ofinfusible fluid; displays a message that the delivery of the bolusvolume requires confirmation using the second remote interface; and onceconfirmation is received by the second remote interface, the secondremote interface communicates the information required for the deliveryof the bolus volume of infusible fluid to the infusion pump.